Shingles is a rash on the side of the face or body, usually affecting persons over 50. The U.S. Food and Drug Administration approved Zostavax as a shingles vaccine in 2006.

The August 2, 2018 order by the U.S. Judicial Panel on Multidistrict Litigation consolidates Zostavax MDL 2848 in the US District Court of Pennsylvania (Eastern District) in front of U.S. District Judge Harvey Bartle, who has been hearing one of the initial Zostavax cases filed in 016. The lawsuits, filed in courts across the country including, Pennsylvania, New Jersey, New York, Wisconsin and Massachusetts, allege that Merck failed to warn that the virus in the vaccine caused shingles, brain damage and death, among other things.

In a move not often seen, defense counsel for Merck had moved for an MDL assigned to Judge Bartle in Pennsylvania or U.S. District Judge James Moody of the Middle District of Florida.

“Issues concerning the design, testing, manufacture, regulatory approval, labeling, and marketing of Zostavax are common to all actions,” wrote the JPML chairwoman, Sarah Vance. “Seven actions are pending in this district, and they are the earliest filed and most advanced actions in this litigation.”

Lead Counsel Comments

“My cases pending before Judge Bartle are the most advanced in the Zostavax litigation,” said Mark Sadaka of The Law Offices of Sadaka Associates in Englewood, New Jersey, a plaintiffs lawyer who supported sending the cases to Bartle. “Merck has already produced millions of pages of documents in my cases in the Easter District of Pennsylvania. Judge Bartle has already decided two summary judgment motions. I look forward to working together with other plaintiffs counsel to finally move our cases to trial.”

Other plaintiffs lawyers had formally opposed creation of an MDL.

Marc J. Bern & Partners in New York, a firm with by far the most individual plaintiffs in the country—over 5,000 Zostavax clients stated “we will be looking to be leaders in this MDL” and “certainly, Judge Bartle is a judge with long experience, has handled successfully other MDL’s” said name partner Marc Bern.

Two important FDA approved changes to the warning label of Merck Pharmaceutical’s shingles vaccine, Zostavax, have been made since the controversial drug was introduced in 2006. The first was in August 2014, when, in addition to potentially causing chickenpox, another side effect was added: shingles! That’s right. The vaccine that had been – and continues to be — aggressively marketed to prevent seniors from contracting this excruciating condition was found to actually cause shingles in some individuals.

The FDA approved a label change to warn those who prescribe the Zostavax vaccine of another potential side effect: “Eye Disorders: necrotizing retinitis.”

According to the authors of a Health Sciences Institute (HSI) article in January, 2016, “UCLA researchers found that only one in 175 people who get the vaccine will be able to dodge a shingles flare-up.” While Merck claims Zostavax is 50% effective, in the placebo group, 3.3 percent of the study participants developed shingles, compared to 1.6 percent in the vaccine group. So, while that is a 50% difference, the real, absolute risk reduction is just 1.7 percentage points.

The JPML was aware of certain issues related to creation of MDL 2858, may delay cases for some plaintiffs, many of whom are older, but coordination of the litigation would help resolve all the cases, “even if some parties might experience inconvenience or delay.”

The JPML order does not apply to lawsuits brought on behalf of 300 plaintiffs in California state court and 800 plaintiffs in New Jersey state court.

One of the lawsuits filed by female plaintiff Joria Bentley from Nevada, claims she suffered high blood pressure, an eye injury and other side effects from Merck & Co.’s Zostavax shingles vaccine in Zostavax litigation filed in the Philadelphia’s Court of Common Pleas. Ms. Bentley claims in her complaint that the patient information sheet, label and prescribing information that accompanied the vaccine did not provide any warning of the risk of viral infection and cites to the many instances of adverse events and other reports on medical issues caused by Zostavax.

Patients who received the injections are filing product liability lawsuits against Merck, alleging the company produced and sold an “unreasonably dangerous vaccine” that caused serious injuries after vaccination. Hailing from a range of states including Louisiana, South Carolina, Tennessee, Michigan and Wisconsin, the plaintiffs filed their suit in Merck’s home state of New Jersey. Instead of preventing shingles, Zostavax caused the plaintiffs to “contract a persistent strain of herpes zoster,” according to the suit, resulting in painful outbreaks, hospital visits and post-herpetic neuralgia in two cases.

The common allegations in all complaints are negligence, defective design, failure to warn, breach of express and implied warranties, misrepresentation involving risk of physical harm and unjust enrichment.

“Merck knew, or should have known, that its product caused viral infection, and was therefore not safe for administration to consumers,” the suits claim. There are “thousands of complaints” yet to be filed according to one of the lead plaintiff attorneys, adding “I think Merck has failed terribly to warn about the very serious side effects and the failure of the vaccine to do what they claim it does” as Merck continues to profit from

National Vaccine Information Center

NVIC provides links and resources such as the manufacturer product information inserts for Zostavax and shingles.

This information is for educational purposes only and is not intended as medical advice.

What is Zostavax?

Zostavax is a vaccine made by pharmaceutical giant Merck, and approved by the U.S. Food and Drug Administration in 2006. It was the only approved shingles vaccine in the United States until late 2017, which allowed the company to earn as much as $749 million in sales from the vaccine in 2016, according to reports.

This vaccine is designed to reduce the risk of getting herpes zoster — a painful and debilitating condition commonly known as “shingles” — in individuals ages 50 years and older, who are at increased risk of developing the virus. Zostavax is typically recommended for people aged 60 years and older by the U.S. Centers for Disease Control and Prevention, and doctors commonly give the vaccine in a one-dose shot.

Zostavax differs from some vaccines in that it contains a live, but weakened form of the herpes zoster virus (this is officially referred to as a “live, attenuated virus”). People with weakened immune systems cannot receive these types of vaccines.

(MASS TORT NEXUS MEDIA) Glyphosate is the most widely used agricultural based chemical product in history, starting when Monsanto introduced it in 1974, and worldwide use exploded after 1996 when Monsanto began selling “Roundup-ready” seeds- engineered to resist the herbicide, with now possibly catastrophic consequences in the United States.

More than 2.6 billion pounds of the chemical has been spread on U.S. farmlands and yards between 1992 and 2012, according to the U.S. Geological Survey. Roundup traces have been detected in over 50% of the food products being consumed in the US marketplace in numerous independent studies.

Monsanto earns $1.9 billion a year from Roundup and $10.2 billion from “seeds and genomics,” most of that category being Roundup-ready seeds.

In June, German pharmaceutical giant Bayer completed its $63 billion acquisition of Monsanto after approval by U.S. and European regulators, even though the Monsanto name may disappear, the link between cancer and glyphosate will remain long after the merger. Will Bayer decide to settle or take the thousands of lawsuits to trial that are pending in federal and state courts across the country? Although U.S. and European regulators have concluded Roundup’s active ingredient glyphosate is safe, the World Health Organization’s International Agency for Research on Cancer classified it in 2015 as a probable human carcinogen, triggering over 5,000 lawsuits against Monsanto in the United States.

Plaintiff DeWayne Johnson’s skin-based non-Hodgkin lymphoma, was caused by his use of Monsanto’s “Roundup Weed Killer” and Monsanto has gone to great lengths to suppress any links between Roundup and cancer.

The current state court trial in California has shown the extraordinary lengths that Monsanto has gone to in order to suppress and manipulate hard core science and research results around the world that showed clear links between Glyphosate and Cancer, specifically non-hodgkins lymphoma.

To show the high level of interest in the Monsanto “Roundup” abuses, last week musician Neil young and actress Darryl Hannah were in the DeWayne Johnson courtroom, which reflects Young’s ongoing campaign against the many abuses of Monsanto placed upon the US farmers and others around the world. He even released a 2015 album titled “The Monsanto Years” along with a documentary “Seeding Fear” of which Young co-produced related to Monsanto legal action against Alabama farmer Michael White, over its GMO patented seeds. Link to “Seeding Fear can be found here.

In addition to the Johnson state court case, there is the Monsanto Roundup Multidistrict Litigation No. 2741 in the US District Court of California, Northern District where the same cancer links are claimed. Documents released in the Johnson trial and in the MDL ( see Roundup (Monsanto) MDL 2741 USDC ND California) have raised many new questions about the company’s efforts to influence the public opinion by collusion and steering of data published by the media, authors and scientific research publications, and revealed internal debate over the safety of the Monsanto’s weed killer Roundup.

The active ingredient is glyphosate, the most common weed killer in the world and is used around the world on farm crops and by home gardeners, with the largest market being the USA. While Roundup’s relative safety has been upheld by most regulators, the thelitigation against Monsanto and Roundup, pending in US District Court in San Francisco continues to raise questions about the company’s practices and the product itself. Thousands of plaintiffs from across the USA have filed suit against Monsanto-Roundup and as details of Monsanto’s attempt to suppress and influence the release of damaging scientific data are released the number of cases will only increase. There has been documented evidence introduced that shows Monsanto influenced high level US Environmental Protection Agency (EPA) executives to suppress data and the release of reports that showed Roundup (glyphosate) was dangerous and suspected of causing cancer. Jess Rowland, EPA Regulatory Affairs Manager, stopped the release of a government study that was key in the investigation into the carcinogenic effects of Roundup’s primary ingredient glyphosate by the Agency for Toxic Substances and Disease Registry, see EPA’s Jess Rowland Stops Release of Report on Glyphosate as Cancer Agent. Rowland left the EPA in early 2017 and went on to become a highly paid consultant for Monsanto.

There are numerous documents and media articles that underscore the lengths to which the agrochemical company has taken to protect its image, and the dangers of Roundup. Documents show that Henry I. Miller, an academic and a vocal proponent of genetically modified crops, asked Monsanto to draft an article for him that largely mirrored one that appeared under his name on Forbes’s website in 2015. Mr. Miller could not be reached for comment.

A similar issue appeared in academic research. An academic involved in writing research funded by Monsanto, John Acquavella, a former Monsanto employee, appeared to express concern with the process see Monsanto internal e-mail expressing concern over Roundup , in the 2015 email to a Monsanto executive, “I can’t be part of deceptive authorship on a presentation or publication.” He also said of the way the company was trying to present the authorship: “We call that ghost writing and it is unethical.”

A Monsanto official said the comments were the result of “a complete misunderstanding” that had been “worked out,” while Mr. Acquavella stated via mail that “there was no ghostwriting” and that his comments had been related to an early draft and a question over authorship that was resolved. Even though there are other documents that refute this version of Monsanto’s “official” statement.

Monsanto has been shown to have actively ghostwritten, drafted and offered direction on formal EPA studies, press releases and other “official” documents, introduced in the pending Roundup federal litigation.

The documents also show internal discussions about Roundup’s safety. “If somebody came to me and said they wanted to test Roundup I know how I would react — with serious concern,” one Monsanto scientist wrote in an internal email in 2001.

Monsanto said it was outraged by the documents’ release by a law firm involved in the litigation, although the documents are now public court records, which Monsanto attempted to suppress being introduced into the litigation again and again since the start of the Roundup lawsuits.

Brent Wisner, a partner at Baum, Hedlund, Aristei & Goldman, the firm that released the documents, said Monsanto had erred by not filing a required motion seeking continued protection of the documents. Monsanto said no such filing was necessary.

“Now the world gets to see these documents that would otherwise remain secret”, per Mr. Wisner.

To reflect “official corporate collusion and influence” see Mr. Miller’s 2015 article on Forbes’s website which was an attack on the findings of the International Agency for Research on Cancer, a branch of the World Health Organization that had labeled glyphosate a probable carcinogen, a finding disputed by other regulatory bodies. In the email traffic, Monsanto asked Mr. Miller if he would be interested in writing an article on the topic, and he said, “I would be if I could start from a high-quality draft.”

The article was authored by Mr. Miller and with the assertion that “opinions expressed by Forbes Contributors are their own.” The magazine did not mention any involvement by Monsanto in preparing the article, as most co-authored articles provide.

“That was a collaborative effort, a function of the outrage we were hearing from many people on the attacks on glyphosate,” Mr. Partridge of Monsanto said. “This is not a scientific, peer-reviewed journal. It’s an op-ed we collaborated with him on.”

After disclosure of the stories origin, Forbes removed the story from its website and said that it ended its relationship with Mr. Miller amid the revelations.

“All contributors to Forbes sign an agreement requiring them to disclose any potential conflicts of interest and only publish content that is their own original writing,” stated a Forbes representative. “When it came to our attention that Mr. Miller violated these terms, we removed his blog from Forbes.com and ended our relationship with him.”

Mr. Miller’s work has also appeared in the opinion pages of The New York Times, which reflects the long reach of Monsanto’s attempts to influence public opinion.

“We have never paid Dr. Miller,” said Sam Murphey, a spokesman for Monsanto. “Our scientists have never collaborated with Dr. Miller on his submissions to The New York Times. Our scientists have on occasion collaborated with Dr. Miller on other pieces.” This statement alone reflects the formal relationship between Miller and Monsanto.

James Dao, the Op-Ed editor of The Times, said in a statement, “Op-Ed contributors to The Times must sign a contract requiring them to avoid any conflict of interest, and to disclose any financial interest in the subject matter of their piece.” Miller and Monsanto did not comment on the apparent violation of this Times policy.

The documents also show that the ongoing debate outside Monsanto about glyphosate safety and Roundup, was also taking place within the company.

In a 2002 email, a Monsanto executive said, “What I’ve been hearing from you is that this continues to be the case with these studies — Glyphosate is O.K. but the formulated product (and thus the surfactant) does the damage.”

As to the internal Monsanto views of a causation relationship between cancer and Roundup, where a different Monsanto executive tells others via e-mail see 2003 Monsanto email, “You cannot say that Roundup is not a carcinogen … we have not done the necessary testing on the formulation to make that statement.”

She adds, however, that “we can make that statement about glyphosate and can infer that there is no reason to believe that Roundup would cause cancer.”

The documents also show that A. Wallace Hayes, the former editor of a journal, Food and Chemical Toxicology, has had a contractual relationship with Monsanto. In a further example of Monsanto collusion and influence in 2013, while he was still editor, Mr. Hayes retracted a key study damaging to Monsanto that found that Roundup, and genetically modified corn, could cause cancer and early death in rats.

Mr. Hayes made a statement that he wasn’t under contract with Monsanto at the time of the retraction, however he was compensated by Monsanto for the article after he left the journal. This seems to be a very indirect method of exerting influence on the public opinion via a direct method of paying for favorable treatment and influence by Monsanto.

“Monsanto played no role whatsoever in the decision that was made to retract,” he said. “It was based on input that I got from some very well-respected people, and also my own evaluation.” If this statement is accurate, why would Monsanto pay Mr. Hayes for an article determined to be inaccurate or misleading other than the retraction was of some benefit to Monsanto.

Monsanto has been proven time and time again to be directly responsible for corporate sponsored collusion, influence peddling in both the public and private sectors and manipulation of data released to the public regarding the now known carcinogenic links of exposure to Monsanto’s primary product, Roundup and the main ingredient glyphosate.

(MASS TORT NEXUS MEDIA) Glyphosate is the most widely used agricultural based chemical product in history, starting when Monsanto introduced it in 1974, and worldwide use exploded after 1996 when Monsanto began selling “Roundup-ready” seeds- engineered to resist the herbicide, with now possibly catastrophic consequences in the United States.

More than 2.6 billion pounds of the chemical has been spread on U.S. farmlands and yards between 1992 and 2012, according to the U.S. Geological Survey. Roundup traces have been detected in over 50% of the food products being consumed in the US marketplace in numerous independent studies.

Monsanto earns $1.9 billion a year from Roundup and $10.2 billion from “seeds and genomics,” most of that category being Roundup-ready seeds.

In June, German pharmaceutical giant Bayer completed its $63 billion acquisition of Monsanto after approval by U.S. and European regulators, even though the Monsanto name may disappear, the link between cancer and glyphosate will remain long after the merger. Will Bayer decide to settle or take the thousands of lawsuits to trial that are pending in federal and state courts across the country? Although U.S. and European regulators have concluded Roundup’s active ingredient glyphosate is safe, the World Health Organization’s International Agency for Research on Cancer classified it in 2015 as a probable human carcinogen, triggering over 5,000 lawsuits against Monsanto in the United States.

Plaintiff DeWayne Johnson’s skin-based non-Hodgkin lymphoma, was caused by his use of Monsanto’s “Roundup Weed Killer” and Monsanto has gone to great lengths to suppress any links between Roundup and cancer.

The current state court trial in California has shown the extraordinary lengths that Monsanto has gone to in order to suppress and manipulate hard core science and research results around the world that showed clear links between Glyphosate and Cancer, specifically non-hodgkins lymphoma.

To show the high level of interest in the Monsanto “Roundup” abuses, last week musician Neil young and actress Darryl Hannah were in the DeWayne Johnson courtroom, which reflects Young’s ongoing campaign against the many abuses of Monsanto placed upon the US farmers and others around the world. He even released a 2015 album titled “The Monsanto Years” along with a documentary “Seeding Fear” of which Young co-produced related to Monsanto legal action against Alabama farmer Michael White, over its GMO patented seeds. Link to “Seeding Fear can be found here.

In addition to the Johnson state court case, there is the Monsanto Roundup Multidistrict Litigation No. 2741 in the US District Court of California, Northern District where the same cancer links are claimed. Documents released in the Johnson trial and in the MDL ( see Roundup (Monsanto) MDL 2741 USDC ND California) have raised many new questions about the company’s efforts to influence the public opinion by collusion and steering of data published by the media, authors and scientific research publications, and revealed internal debate over the safety of the Monsanto’s weed killer Roundup.

The active ingredient is glyphosate, the most common weed killer in the world and is used around the world on farm crops and by home gardeners, with the largest market being the USA. While Roundup’s relative safety has been upheld by most regulators, the thelitigation against Monsanto and Roundup, pending in US District Court in San Francisco continues to raise questions about the company’s practices and the product itself. Thousands of plaintiffs from across the USA have filed suit against Monsanto-Roundup and as details of Monsanto’s attempt to suppress and influence the release of damaging scientific data are released the number of cases will only increase. There has been documented evidence introduced that shows Monsanto influenced high level US Environmental Protection Agency (EPA) executives to suppress data and the release of reports that showed Roundup (glyphosate) was dangerous and suspected of causing cancer. Jess Rowland, EPA Regulatory Affairs Manager, stopped the release of a government study that was key in the investigation into the carcinogenic effects of Roundup’s primary ingredient glyphosate by the Agency for Toxic Substances and Disease Registry, see EPA’s Jess Rowland Stops Release of Report on Glyphosate as Cancer Agent. Rowland left the EPA in early 2017 and went on to become a highly paid consultant for Monsanto.

There are numerous documents and media articles that underscore the lengths to which the agrochemical company has taken to protect its image, and the dangers of Roundup. Documents show that Henry I. Miller, an academic and a vocal proponent of genetically modified crops, asked Monsanto to draft an article for him that largely mirrored one that appeared under his name on Forbes’s website in 2015. Mr. Miller could not be reached for comment.

A similar issue appeared in academic research. An academic involved in writing research funded by Monsanto, John Acquavella, a former Monsanto employee, appeared to express concern with the process see Monsanto internal e-mail expressing concern over Roundup , in the 2015 email to a Monsanto executive, “I can’t be part of deceptive authorship on a presentation or publication.” He also said of the way the company was trying to present the authorship: “We call that ghost writing and it is unethical.”

A Monsanto official said the comments were the result of “a complete misunderstanding” that had been “worked out,” while Mr. Acquavella stated via mail that “there was no ghostwriting” and that his comments had been related to an early draft and a question over authorship that was resolved. Even though there are other documents that refute this version of Monsanto’s “official” statement.

Monsanto has been shown to have actively ghostwritten, drafted and offered direction on formal EPA studies, press releases and other “official” documents, introduced in the pending Roundup federal litigation.

The documents also show internal discussions about Roundup’s safety. “If somebody came to me and said they wanted to test Roundup I know how I would react — with serious concern,” one Monsanto scientist wrote in an internal email in 2001.

Monsanto said it was outraged by the documents’ release by a law firm involved in the litigation, although the documents are now public court records, which Monsanto attempted to suppress being introduced into the litigation again and again since the start of the Roundup lawsuits.

Brent Wisner, a partner at Baum, Hedlund, Aristei & Goldman, the firm that released the documents, said Monsanto had erred by not filing a required motion seeking continued protection of the documents. Monsanto said no such filing was necessary.

“Now the world gets to see these documents that would otherwise remain secret”, per Mr. Wisner.

To reflect “official corporate collusion and influence” see Mr. Miller’s 2015 article on Forbes’s website which was an attack on the findings of the International Agency for Research on Cancer, a branch of the World Health Organization that had labeled glyphosate a probable carcinogen, a finding disputed by other regulatory bodies. In the email traffic, Monsanto asked Mr. Miller if he would be interested in writing an article on the topic, and he said, “I would be if I could start from a high-quality draft.”

The article was authored by Mr. Miller and with the assertion that “opinions expressed by Forbes Contributors are their own.” The magazine did not mention any involvement by Monsanto in preparing the article, as most co-authored articles provide.

“That was a collaborative effort, a function of the outrage we were hearing from many people on the attacks on glyphosate,” Mr. Partridge of Monsanto said. “This is not a scientific, peer-reviewed journal. It’s an op-ed we collaborated with him on.”

After disclosure of the stories origin, Forbes removed the story from its website and said that it ended its relationship with Mr. Miller amid the revelations.

“All contributors to Forbes sign an agreement requiring them to disclose any potential conflicts of interest and only publish content that is their own original writing,” stated a Forbes representative. “When it came to our attention that Mr. Miller violated these terms, we removed his blog from Forbes.com and ended our relationship with him.”

Mr. Miller’s work has also appeared in the opinion pages of The New York Times, which reflects the long reach of Monsanto’s attempts to influence public opinion.

“We have never paid Dr. Miller,” said Sam Murphey, a spokesman for Monsanto. “Our scientists have never collaborated with Dr. Miller on his submissions to The New York Times. Our scientists have on occasion collaborated with Dr. Miller on other pieces.” This statement alone reflects the formal relationship between Miller and Monsanto.

James Dao, the Op-Ed editor of The Times, said in a statement, “Op-Ed contributors to The Times must sign a contract requiring them to avoid any conflict of interest, and to disclose any financial interest in the subject matter of their piece.” Miller and Monsanto did not comment on the apparent violation of this Times policy.

The documents also show that the ongoing debate outside Monsanto about glyphosate safety and Roundup, was also taking place within the company.

In a 2002 email, a Monsanto executive said, “What I’ve been hearing from you is that this continues to be the case with these studies — Glyphosate is O.K. but the formulated product (and thus the surfactant) does the damage.”

As to the internal Monsanto views of a causation relationship between cancer and Roundup, where a different Monsanto executive tells others via e-mail see 2003 Monsanto email, “You cannot say that Roundup is not a carcinogen … we have not done the necessary testing on the formulation to make that statement.”

She adds, however, that “we can make that statement about glyphosate and can infer that there is no reason to believe that Roundup would cause cancer.”

The documents also show that A. Wallace Hayes, the former editor of a journal, Food and Chemical Toxicology, has had a contractual relationship with Monsanto. In a further example of Monsanto collusion and influence in 2013, while he was still editor, Mr. Hayes retracted a key study damaging to Monsanto that found that Roundup, and genetically modified corn, could cause cancer and early death in rats.

Mr. Hayes made a statement that he wasn’t under contract with Monsanto at the time of the retraction, however he was compensated by Monsanto for the article after he left the journal. This seems to be a very indirect method of exerting influence on the public opinion via a direct method of paying for favorable treatment and influence by Monsanto.

“Monsanto played no role whatsoever in the decision that was made to retract,” he said. “It was based on input that I got from some very well-respected people, and also my own evaluation.” If this statement is accurate, why would Monsanto pay Mr. Hayes for an article determined to be inaccurate or misleading other than the retraction was of some benefit to Monsanto.

Monsanto has been proven time and time again to be directly responsible for corporate sponsored collusion, influence peddling in both the public and private sectors and manipulation of data released to the public regarding the now known carcinogenic links of exposure to Monsanto’s primary product, Roundup and the main ingredient glyphosate.

The Johnson vs. Monsanto trial verdict will be posted as soon as it becomes available.

Employer Costs Pass $2.6 Billion Per Year With 50% Used to Cover Children

By Mark A. York (August 3, 2018)

Employers spent $2.6 billion on opioid addiction in 2016

$1.5 billion+ was spent on children with opiate addiction issues

(MASS TORT NEXUS MEDIA) The now commonly known costs associated with employers treating opioid addiction and the affiliated issues have increased eight hundred percent since 2004 to an eye-watering $2.6 billion in 2016, a new report reveals.

The latest analysis shows that half of the cost was spent covering employees’ children.

A recent Kaiser Family Foundation report found that prescription use of addictive painkillers among people with employer offered health coverage is now at the lowest levels in 10 years.

This comes shortly after a CDC study revealed there was been a nearly 30 percent increase in overdoses between 2015 and 2016.

According to the Centers for Disease Control and Prevention, opioids killed more than 42,000 people in 2016, more than any year on record.

With 40 percent of those deaths involving a prescription opioid such as Oxycontin and Vicodin and other widely prescribed opiates. This has also resulted in the multi-billion lawsuits filed against Opioid Big Pharma drug makers and distributors by cities, counties and states across the country, see Mass Tort Nexus Briefcase “Opioid Litigation Versus Opiate Prescription Industry MDL 2804, US District Court of Ohio”with the drug makers and distributors scrambling to defend the opiate marketing strategies that have caused billions and billions of dollars in costs, medical damages and loss of productivity annually in the United States.

The Kaiser Family Foundation found that the $2.6 billion spending cost companies and workers about $26 per enrollee in 2016, which now appears to be a “man-made” healthcare cost increase associated with the widely accepted Opiate Big Pharma marketing practices over the last 20 years. This include telling doctors and the healthcare industry that “opiates are not as addictive as they used to be” and “we’ve altered the drug compound to control opiate release” which was the widely used Purdue Pharma marketing strategy.

Employers have been limiting insurance coverage of opioids because of concerns about addiction. The report found that spending on opioid prescriptions falling 27 percent from a peak in 2009 – when 17.3 percent of large employer plan enrollees had at least one opioid prescription during that year. However, by 2016, that number dropped to 13.6 percent.

These drugs relieve pain by attaching to specific proteins called opioid receptors, which are found on nerve cells in the brain, spinal cord, gastrointestinal tract, and other organs in the body. When they attach to these receptors, they reduce the perception of pain.

[STUDY OBJECTIVES:The prevalence of opioid use disorder (OUD) during pregnancy is increasing. Practical recommendations will help providers treat pregnant women with OUD and reduce potentially negative health consequences for mother, fetus, and child. This article summarizes the literature review conducted using the RAND/University of California, Los Angeles Appropriateness Method project completed by the US Department of Health and Human Services Substance Abuse and Mental Health Services Administration to obtain current evidence on treatment approaches for pregnant and parenting women with OUD and their infants and children]

Prescription opioids and illicit drugs have become incredibly pervasive throughout the US, and things are only getting worse.

In the early 2000s, the FDA and CDC started to notice a steady increase in cases of opioid addiction and overdose. In 2013, they issued guidelines to curb addiction.

However, that same year – now regarded as the year the epidemic took hold – a CDC report revealed an unprecedented surge in rates of opioid addiction.

Overdose deaths are now the leading cause of death among young Americans – killing more in a year than were ever killed annually by HIV, gun violence or car crashes.

Preliminary CDC data published by the New York Times shows US drug overdose deaths surged 19 percent to at least 59,000 in 2016.

That is up from 52,404 in 2015, and double the death rate a decade ago.

It means that for the first time drug overdoses are the leading cause of death for Americans under 50 years old.

The data lays bare the bleak state of America’s opioid addiction crisis fueled by deadly manufactured drugs like fentanyl.

These drugs also effect the brain regions involved in reward, so it can also produce a sense of pleasure by triggering the same processes that make people feel good when they are having fun or sex.

Experts say many people’s first contact with opioids is through some form of social contact: either a friend who was sent home with Oxycontin after a surgical procedure or a relative who received an opioid prescription for chronic pain.

‘Opioids, are not a bacteria virus, but the drug, in this case, spreads through social networks…even in some ways a virus, like HIV, is spread to a great degree through social networks,’ he added.

Due to the link between hospitals and the opioid crisis, doctors have been coming up with innovative ways to curb the epidemic.

However, hospitals have been doing their part in trying to curb the opioid epidemic.

For instance, the ER department at St. Joseph University Medical Center in New Jersey managed to halve the rate of opioid prescriptions by using dry needles and laughing gas to treat chronic pain.

In 2016, the department launched an Alternative to Opiates program that uses trigger point injections and a local anesthetics in lieu of opioids to relieve pain. Other alternative pain relieving methods they used was warm compressors and music – they have a harpist roam the halls playing tunes to soothe the patients.

Dr Mark Rosenberg, chair of emergency medicine, said he and his colleagues founded the program after they realized chronic pain was one of the reasons most patients came to their emergency department.

‘We wanted to develop an aggressive acute pain management program that focused on evidence based principles but avoided opioids,’ Dr Rosenberg said.

St. Joseph University Medical Center isn’t the only hospital to implement this program, Kaiser Permanente has implemented an Integrated Pain Service, an eight-week course designed to educate high-risk opioid patients about pain management.

Some experts have stated that the beginning of the end of the epidemic may be near due to tightened regulations on opioid prescription monitoring, local-level efforts to make naloxone, an anti-overdose drug, and drug-assisted rehabilitation more accessible to high-risk populations. Then there are many more “experts” who state that the opioid crisis and the future affiliated issues are going to be on the healthcare, insurance and socio-economic forefront of America for at least the next generation.

Broken Families, Less Funding

The patterns of parent addiction that overflows into child addiction is something that wasn’t part of the opiate equation until fairly recently, where employer issues now mirror a national trend of multiple generations being addicted to opiates. Largely because of the opioid epidemic, there were 30,000 more children in foster care in 2015 than there were in 2012—an 8 percent increase. In 14 states, from New Hampshire to North Dakota, the number of foster kids rose by more than a quarter between 2011 and 2015, according to data amassed by the Annie E. Casey Foundation.In Texas, Florida, Oregon, and elsewhere, kids have been forced to sleep in state buildings because there were no foster homes available, says advocacy group Children’s Rights. Federal child welfare money has been dwindling for years, leaving state and local funding to fill in the gaps. But Ashtabula County is one of the poorest counties in Ohio, and despite a recent boost in funding, the state contributes the lowest share toward children’s services of any state in the country.

In the USA, Opioid use by women in rural areas is driving the increasing numbers. Tennessee is part of a cluster of states, including Alabama and Kentucky, experiencing some of the highest rates of NAS births. In East Tennessee the problem is particularly acute: Sullivan County alone reported a rate of 50.5 cases of NAS per 1,000 births, the highest rate in the state for five years running.

Tennessee is currently the only state in the country that equates substance abuse while pregnant with aggravated assault, punishable by a 15-year prison sentence. Eighteen other states consider it to be child abuse, and three say its grounds for civil commitment. Four states require drug testing of mothers and 18 require that healthcare professionals report when drug abuse is suspected. There are also 19 states that have created funding for targeted drug treatment programs for pregnant women.

Opponents of the punishment philosophy claim that punishing addicted pregnant women will not stop them from abusing drugs â€“ instead it will stop them from seeking prenatal care. Many also claim that these policies would unfairly punish mothers for drug use compared to fathers. Organizations, such as the American Civil Liberties Union (ACLU) and the American Congress of Obstetricians and Gynecologists (ACOG), have encouraged a treatment over punishment approach for pregnant mothers with drug addictions

Local efforts are now seen as the primary way to address the opioid crisis in children- the attempt to secure federal intervention and support to help curb the opioid crisis has not been a priority of the Trump Administration..

WHITE HOUSE PROMISED ON OPIOIDS BUT DIDN’T DELIVER

But since he took office, Trump’s plans to tackle the epidemic head-on have fizzled. Republicans’ recent effort to repeal and replace Obamacare would slash funding for Medicaid, which is the country’s largest payer for addiction services—and which covers nearly half of Ohio’s prescriptions for the opioid addiction medication buprenorphine. The bill would enable insurers in some states to get out of the Obamacare requirement to cover substance abuse treatment. A memo leaked in May revealed Trump’s plans to effectively eliminate the White House’s drug policy office, cutting its budget by 95 percent. (The administration has since backpedaled on the plans, following bipartisan criticism.) Trump’s 2018 budget proposes substantial cuts to the Administration for Children and Families, the Substance Abuse and Mental Health Services Administration, and the Temporary Assistance for Needy Families program.

Until the governments at the federal, state and local levels can all agree on a long term viable solution to the opioid crisis and the impact on school age children, infants born addicted and society as a whole, the opiate drug crisis will linger for generations long into the future.

(MASS TORT NEXUS MEDIA) In 2017 and continuing into 2018, Big Pharma has been fighting major legal battles related to off-label marketing of drugs for unintended uses. They also engaged in a parallel strategy, where they were influencing the FDA and other policy making agencies behind the scenes in Washington DC. Big Pharma was paying millions to lobbyists, making campaign donations and generally buying influence as they always have. It was a foregone conclusion that with the Trump administration view of , “no regulatory oversight required” that there would be some loosening of the FDA regulatory shackles.

Big Pharma was getting ready for freedom to sell, sell, sell their drugs in any way they could, including off-label marketing of the drugs for unintended use purposes. A corporate policy, that’s technically illegal, yet results in billions of dollars in profits every years for Big Pharma. Then the FDA rolled out an unexpected new proposed rule, in March 2017 cracking down on “off-label’ marketing of drugs. This new rule change wasn’t in Big Pharma’s bests interests, sending the drug industry into a furious lobbying scramble. Bring in the Trump camp and on January 12, 2018 Big Pharma and the army of lobbyists and elected officials that were recruited, seem to have succeeded in stopping the FDA rules change that would have tightened up “off label” marketing of drugs.

This seems to be further evidence of the Trump administration permitting private corporations to control what goes on behind the scenes in federal regulatory agencies these days. The same loosening of enforcement rules has been seen in the EPA as well as in Dept. of Energy oversight enforcement authority. Whatever else you might think about the ramped up Trump vs. Obama administration mindset, this rule delay is an example of the new FDA leadership doing what is in the best interests of those they are supposed to be regulating, the drug makers, and not in the interests of the US consumers.

To put this into perspective, consider the current “Opioid Crisis” gripping the entire country, where “off-label” marketing of opiates for the last 20 years by drug makers, has resulted in thousands of deaths each year, unknown financial losses and the related social impact felt in every state across the country. Another result is the Opiate Prescription Litigation MDL 2804, (see OPIOID CRISIS BRIEFCASE: MDL 2804 OPIATE PRESCRIPTION LITIGATION) where litigation started when hundreds of counties, states and cities and other entities impacted by the catastrophic expense related to combatting the opiate healthcare crisis fought back. The various parties have filed lawsuits against opioid drug makers and distributors, demanding repayment of the billions of dollars spent on addressing the massive costs related to opioid abuse, primarily due to opioid based prescription drugs flooding the country.

When the Obama administration ended on January 9, 2017, the FDA issued a Final Rule on “Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses.’” That “clarification” was meant to enable additional enforcement and control over drug makers rampant “off -label” marketing of drugs for purposes that were never FDA approved. This was an attempt by the FDA to have the ability to punish off-label promotions, where previously the process was a two-step regulatory review, whereby off-label promotions are said to prove an indicated use not included in the label and, thus, not accompanied by adequate directions for use – making the product misbranded. These regulations have been around since the 1950s, but a recent series of court decisions invoking the First Amendment called into question the FDA’s interpretation of “intended use” and its efforts to shut down truthful medical-science communications about potential benefits from off-label use.

In a 2015 proposed rule, the FDA referred to striking the language from regulations permitting the FDA to consider a manufacturer’s mere knowledge of actual use as evidence of intended use, which would have further enabled Big Pharma drug marketing abuses to go unchecked. But then, the FDA’s January 9, 2017 proposal reversed course, stating that retained knowledge of off-label use as evidence of intended use, clarified that any relevant source of evidence, whether circumstantial or direct could demonstrate intended use, and ultimately invoked the dreaded “totality of the evidence” standard. This would have enable the FDA to begin oversight and enforcement of practices such as the blatant and wide open “off-label” marketing of opioid prescription drugs that started in the mid-1990’s and never stopped.

Instead of putting a check on Big Pharma abuses, we have the Trump administration placing a hold on new regulations, and delaying the “intended use” regulation change to March 19, 2018, so that comments could be received and considered, and thereby enabling the Big Pharma “lobby machine” to become fully engaged across all DC circles, ensuring that the FDA changes are effectively put to rest.

The bottom line is that the FDA is now proposing to “delay until further notice” the portions of the final rule amending the FDA’s existing regulations on “off-label” drug use, when describing the types of evidence that may be considered in determining a medical product’s intended uses. The FDA will receive comments on this proposal through February 5, 2018.

Global health care giant Johnson & Johnson (J&J) and its subsidiaries will pay more than $2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider. The global resolution is one of the largest health care fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion.

“The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” stated Eric Holder, then US Attorney General, “This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health care fraud. And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people” he added.

The resolution includes criminal fines and forfeiture for violations of the law and civil settlements based on the False Claims Act arising out of multiple investigations of the company and its subsidiaries.

“When companies put profit over patients’ health and misuse taxpayer dollars, we demand accountability,” said Associate Attorney General Tony West. “In addition to significant monetary sanctions, we will ensure that non-monetary measures are in place to facilitate change in corporate behavior and help ensure the playing field is level for all market participants.”

The Federal Food, Drug, and Cosmetic Act (FDCA) protects the health and safety of the public by ensuring, among other things, that drugs intended for use in humans are safe and effective for their intended uses and that the labeling of such drugs bear true, complete and accurate information. Under the FDCA, a pharmaceutical company must specify the intended uses of a drug in its new drug application to the FDA. Before approval, the FDA must determine that the drug is safe and effective for those specified uses. Once the drug is approved, if the company intends a different use and then introduces the drug into interstate commerce for that new, unapproved use, the drug becomes misbranded. The unapproved use is also known as an “off-label” use because it is not included in the drug’s FDA-approved labeling.

“When pharmaceutical companies interfere with the FDA’s mission of ensuring that drugs are safe and effective for the American public, they undermine the doctor-patient relationship and put the health and safety of patients at risk,” said Director of the FDA’s Office of Criminal Investigations John Roth. “Today’s settlement demonstrates the government’s continued focus on pharmaceutical companies that put profits ahead of the public’s health. The FDA will continue to devote resources to criminal investigations targeting pharmaceutical companies that disregard the drug approval process and recklessly promote drugs for uses that have not been proven to be safe and effective.”

J&J RISPERDAL MARKETING ABUSE

In a related civil complaint filed today in the Eastern District of Pennsylvania, the United States alleges that Janssen marketed Risperdal to control the behaviors and conduct of the nation’s most vulnerable patients: elderly nursing home residents, children and individuals with mental disabilities. The government alleges that J&J and Janssen caused false claims to be submitted to federal health care programs by promoting Risperdal for off-label uses that federal health care programs did not cover, making false and misleading statements about the safety and efficacy of Risperdal and paying kickbacks to physicians to prescribe Risperdal.

“J&J’s promotion of Risperdal for unapproved uses threatened the most vulnerable populations of our society – children, the elderly and those with developmental disabilities,” said U.S. Attorney for the Eastern District of Pennsylvania Zane Memeger. “This historic settlement sends the message that drug manufacturers who place profits over patient care will face severe criminal and civil penalties.”

In its complaint, the government alleges that the FDA repeatedly advised Janssen that marketing Risperdal as safe and effective for the elderly would be “misleading.” The FDA cautioned Janssen that behavioral disturbances in elderly dementia patients were not necessarily manifestations of psychotic disorders and might even be “appropriate responses to the deplorable conditions under which some demented patients are housed, thus raising an ethical question regarding the use of an antipsychotic medication for inappropriate behavioral control.”

The complaint further alleges that J&J and Janssen were aware that Risperdal posed serious health risks for the elderly, including an increased risk of strokes, but that the companies downplayed these risks. For example, when a J&J study of Risperdal showed a significant risk of strokes and other adverse events in elderly dementia patients, the complaint alleges that Janssen combined the study data with other studies to make it appear that there was a lower overall risk of adverse events. A year after J&J had received the results of a second study confirming the increased safety risk for elderly patients taking Risperdal, but had not published the data, one physician who worked on the study cautioned Janssen that “[a]t this point, so long after [the study] has been completed … we must be concerned that this gives the strong appearance that Janssen is purposely withholding the findings.”

The complaint also alleges that Janssen knew that patients taking Risperdal had an increased risk of developing diabetes, but nonetheless promoted Risperdal as “uncompromised by safety concerns (does not cause diabetes).” When Janssen received the initial results of studies indicating that Risperdal posed the same diabetes risk as other antipsychotics, the complaint alleges that the company retained outside consultants to re-analyze the study results and ultimately published articles stating that Risperdal was actually associated with a lower risk of developing diabetes.

The complaint alleges that, despite the FDA warnings and increased health risks, from 1999 through 2005, Janssen aggressively marketed Risperdal to control behavioral disturbances in dementia patients through an “ElderCare sales force” designed to target nursing homes and doctors who treated the elderly. In business plans, Janssen’s goal was to “[m]aximize and grow RISPERDAL’s market leadership in geriatrics and long term care.” The company touted Risperdal as having “proven efficacy” and “an excellent safety and tolerability profile” in geriatric patients.

In addition to promoting Risperdal for elderly dementia patients, from 1999 through 2005, Janssen allegedly promoted the antipsychotic drug for use in children and individuals with mental disabilities. The complaint alleges that J&J and Janssen knew that Risperdal posed certain health risks to children, including the risk of elevated levels of prolactin, a hormone that can stimulate breast development and milk production. Nonetheless, one of Janssen’s Key Base Business Goals was to grow and protect the drug’s market share with child/adolescent patients. Janssen instructed its sales representatives to call on child psychiatrists, as well as mental health facilities that primarily treated children, and to market Risperdal as safe and effective for symptoms of various childhood disorders, such as attention deficit hyperactivity disorder, oppositional defiant disorder, obsessive-compulsive disorder and autism. Until late 2006, Risperdal was not approved for use in children for any purpose, and the FDA repeatedly warned the company against promoting it for use in children.

The government’s complaint also contains allegations that Janssen paid speaker fees to doctors to influence them to write prescriptions for Risperdal. Sales representatives allegedly told these doctors that if they wanted to receive payments for speaking, they needed to increase their Risperdal prescriptions.

In addition to allegations relating to Risperdal, today’s settlement also resolves allegations relating to Invega, a newer antipsychotic drug also sold by Janssen. Although Invega was approved only for the treatment of schizophrenia and schizoaffective disorder, the government alleges that, from 2006 through 2009, J&J and Janssen marketed the drug for off-label indications and made false and misleading statements about its safety and efficacy.

As part of the global resolution, J&J and Janssen have agreed to pay a total of $1.391 billion to resolve the false claims allegedly resulting from their off-label marketing and kickbacks for Risperdal and Invega. This total includes $1.273 billion to be paid as part of the resolution announced today, as well as $118 million that J&J and Janssen paid to the state of Texas in March 2012 to resolve similar allegations relating to Risperdal. Because Medicaid is a joint federal-state program, J&J’s conduct caused losses to both the federal and state governments. The additional payment made by J&J as part of today’s settlement will be shared between the federal and state governments, with the federal government recovering $749 million, and the states recovering $524 million. The federal government and Texas each received $59 million from the Texas settlement.

NURSING HOME PATIENT ABUSES BY J&J

The civil settlement also resolves allegations that, in furtherance of their efforts to target elderly dementia patients in nursing homes, J&J and Janssen paid kickbacks to Omnicare Inc., the nation’s largest pharmacy specializing in dispensing drugs to nursing home patients. In a complaint filed in the District of Massachusetts in January 2010, the United States alleged that J&J paid millions of dollars in kickbacks to Omnicare under the guise of market share rebate payments, data-purchase agreements, “grants” and “educational funding.” These kickbacks were intended to induce Omnicare and its hundreds of consultant pharmacists to engage in “active intervention programs” to promote the use of Risperdal and other J&J drugs in nursing homes. Omnicare’s consultant pharmacists regularly reviewed nursing home patients’ medical charts and made recommendations to physicians on what drugs should be prescribed for those patients. Although consultant pharmacists purported to provide “independent” recommendations based on their clinical judgment, J&J viewed the pharmacists as an “extension of [J&J’s] sales force.”

J&J and Janssen have agreed to pay $149 million to resolve the government’s contention that these kickbacks caused Omnicare to submit false claims to federal health care programs. The federal share of this settlement is $132 million, and the five participating states’ total share is $17 million. In 2009, Omnicare paid $98 million to resolve its civil liability for claims that it accepted kickbacks from J&J and Janssen, along with certain other conduct.

“Consultant pharmacists can play an important role in protecting nursing home residents from the use of antipsychotic drugs as chemical restraints,” said U.S. Attorney for the District of Massachusetts Carmen Ortiz. “This settlement is a reminder that the recommendations of consultant pharmacists should be based on their independent clinical judgment and should not be the product of money paid by drug companies.”

OFF-LABEL USE OF HEART DRUG NATRECOR

The civil settlement announced today also resolves allegations that J&J and another of its subsidiaries, Scios Inc., caused false and fraudulent claims to be submitted to federal health care programs for the heart failure drug Natrecor. In August 2001, the FDA approved Natrecor to treat patients with acutely decompensated congestive heart failure who have shortness of breath at rest or with minimal activity. This approval was based on a study involving hospitalized patients experiencing severe heart failure who received infusions of Natrecor over an average 36-hour period.

In a civil complaint filed in 2009 in the Northern District of California, the government alleged that, shortly after Natrecor was approved, Scios launched an aggressive campaign to market the drug for scheduled, serial outpatient infusions for patients with less severe heart failure – a use not included in the FDA-approved label and not covered by federal health care programs. These infusions generally involved visits to an outpatient clinic or doctor’s office for four- to six-hour infusions one or two times per week for several weeks or months.

The government’s complaint alleged that Scios had no sound scientific evidence supporting the medical necessity of these outpatient infusions and misleadingly used a small pilot study to encourage the serial outpatient use of the drug. Among other things, Scios sponsored an extensive speaker program through which doctors were paid to tout the purported benefits of serial outpatient use of Natrecor. Scios also urged doctors and hospitals to set up outpatient clinics specifically to administer the serial outpatient infusions, in some cases providing funds to defray the costs of setting up the clinics, and supplied providers with extensive resources and support for billing Medicare for the outpatient infusions.

As part of today’s resolution, J&J and Scios have agreed to pay the federal government $184 million to resolve their civil liability for the alleged false claims to federal health care programs resulting from their off-label marketing of Natrecor. In October 2011, Scios pleaded guilty to a misdemeanor FDCA violation and paid a criminal fine of $85 million for introducing Natrecor into interstate commerce for an off-label use.

“This case is an example of a drug company encouraging doctors to use a drug in a way that was unsupported by valid scientific evidence,” said First Assistant U.S. Attorney for the Northern District of California Brian Stretch. “We are committed to ensuring that federal health care programs do not pay for such inappropriate uses, and that pharmaceutical companies market their drugs only for uses that have been proven safe and effective.”

Non-Monetary Provisions of the Global Resolution and Corporate Integrity Agreement

In addition to the criminal and civil resolutions, J&J executed a five-year Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General (HHS-OIG). The CIA includes provisions requiring J&J to implement major changes to the way its pharmaceutical affiliates do business. Among other things, the CIA requires J&J to change its executive compensation program to permit the company to recoup annual bonuses and other long-term incentives from covered executives if they, or their subordinates, engage in significant misconduct. J&J may recoup monies from executives who are current employees and from those who have left the company. The CIA also requires J&J’s pharmaceutical businesses to implement and maintain transparency regarding their research practices, publication policies and payments to physicians. On an annual basis, management employees, including senior executives and certain members of J&J’s independent board of directors, must certify compliance with provisions of the CIA. J&J must submit detailed annual reports to HHS-OIG about its compliance program and its business operations.

“OIG will work aggressively with our law enforcement partners to hold companies accountable for marketing and promotion that violate laws intended to protect the public,” said Inspector General of the U.S. Department of Health and Human Services Daniel R. Levinson. “Our compliance agreement with Johnson & Johnson increases individual accountability for board members, sales representatives, company executives and management. The agreement also contains strong monitoring and reporting provisions to help ensure that the public is protected from future unlawful and potentially harmful off-label marketing.”

FEDERAL AND STATE JOINT CRIMINAL INVESTIGATIONS

This resolution marks the culmination of an extensive, coordinated investigation by federal and state law enforcement partners that is the hallmark of the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which fosters government collaborations to fight fraud. Announced in May 2009 by Attorney General Eric Holder and Health and Human Services Secretary Kathleen Sebelius, the HEAT initiative has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation.

The criminal cases against Janssen and Scios were handled by the U.S. Attorney’s Offices for the Eastern District of Pennsylvania and the Northern District of California and the Civil Division’s Consumer Protection Branch. The civil settlements were handled by the U.S. Attorney’s Offices for the Eastern District of Pennsylvania, the Northern District of California and the District of Massachusetts and the Civil Division’s Commercial Litigation Branch. Assistance was provided by the HHS Office of Counsel to the Inspector General, Office of the General Counsel-CMS Division, the FDA’s Office of Chief Counsel and the National Association of Medicaid Fraud Control Units.

This matter was investigated by HHS-OIG, the Department of Defense’s Defense Criminal Investigative Service, the FDA’s Office of Criminal Investigations, the Office of Personnel Management’s Office of Inspector General, the Department of Veterans Affairs, the Department of Labor, TRICARE Program Integrity, the U.S. Postal Inspection Service’s Office of the Inspector General and the FBI.

One of the most powerful tools in the fight against Medicare and Medicaid financial fraud is the False Claims Act. Since January 2009, the Justice Department has recovered a total of more than $16.7 billion through False Claims Act cases, with more than $11.9 billion of that amount recovered in cases involving fraud against federal health care programs.

The department enforces the FDCA by prosecuting those who illegally distribute unapproved, misbranded and adulterated drugs and medical devices in violation of the Act. Since 2009, fines, penalties and forfeitures that have been imposed in connection with such FDCA violations have totaled more than $6 billion.

The civil settlements described above resolve multiple lawsuits filed under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the government and to share in any recovery. From the federal government’s share of the civil settlements announced today, the whistleblowers in the Eastern District of Pennsylvania will receive $112 million, the whistleblowers in the District of Massachusetts will receive $27.7 million and the whistleblower in the Northern District of California will receive $28 million. Except to the extent that J&J subsidiaries have pleaded guilty or agreed to plead guilty to the criminal charges discussed above, the claims settled by the civil settlements are allegations only, and there has been no determination of liability

With the Trump Administration still claiming that no regulatory oversight is needed to monitor the US drug industry, that they can self-regulate, it appears that there will be no letup in the rampant “off-label: and unintended use marketing of pharmaceutical drugs in the United States. The one way that Big Pharma is held accountable is in the courtroom, although financial damages and penalties against the drug companies amounting to billions of dollars each year being awarded by juries, wont change FDA policy, it does provide a small amount of official recognition that there are ongoing abuses by the pharmaceutical industry in the USA.

(MASS TORT NEXUS MEDIA)

A COMPARISON OF OXYCODONE PRESCRIBING

In the first six months of 2010, Ohio doctors and health care practitioners bought the second-largest number of oxycodone doses in the country at just under 1 million pills.

Florida doctors bought 40.8 million in the same period, the comparison is astounding, yet it flew under the DEA, Opioid Big Pharma and everyone elses radar for years and years.

Of the country’s top 50 oxycodone-dispensing clinics, 49 were in Florida. From August 2008 to November 2009, a new pain clinic opened in Broward and Palm Beach counties on average of every three days.

Pharmacies and distributors are at fault as well, pharmacies ordered jaw-dropping numbers of pills from opioid drug distributors, the middlemen between manufacturers and pharmacies.

90 of 100 of the nation’s top 100 oxy-buying doctors in 2010, were in Florida. 49 of 50 of the country’s top oxy-dispensing clinics were in Florida. For some reason this didn’t raise an alarm or cause anyone to look further at the time.

Purdue Pharma New What Was Happening In Florida

Purdue and the Sacklers chose to ignore Florida, because apparently nobody there sued them or complained. In 2007, in other states, the infamous drug maker and three of its executives pled guilty in federal court and paid out $634.5 million in fines for purposefully misleading regulators, doctors, and patients about the addictiveness of their opioid painkiller. Around the same time, Purdue was also sued by several states, including Washington, over similar allegations. Purdue agreed to a $19.5 million multi-state settlement. And in 2015, Purdue settled a case with Kentucky, agreeing to pay $24 million.

As part of the state settlements, Purdue was supposed to set up monitoring programs to make sure that its opioid drug didn’t wind up in the wrong hands. It was supposed to watch out for shady pharmacies, unusually large orders, or suspiciously frequent orders. But on this front, Everett alleges that Purdue once again put profits over people.

Obviously, this was ignored as the Florida based “Oxy Expres”; rolled on for years and years with np input, comment or oversight by Purdue Pharma and the Sackler family other than “show me the money” and enjoying a life of luxury on the misery created and managed in the Purdue Pharma boardroom. But, the Purdue boardroom isn’t the only guilty “Opioid Big Pharma” industry player who designed and supported the opioid prescribing crisis.

Why Distributors Are Liable

Cardinal Health, one of the nation’s biggest distributors, sold two CVS pharmacies in Sanford a combined 3 million doses of oxycodone, flooding the town of 54,000 with an average of 250,000 oxycodone pills every month.

West of Jupiter, a Walgreens drug distribution center sold 2.2 million tablets to a single Walgreens’ pharmacy in tiny Hudson, a roughly six-month supply for each of its 12,000 residents. It shipped more than 1.1 million pills to each of two Fort Pierce Walgreens pharmacies.

For 40 days starting in late 2010, the distribution center shipped 3,271 bottles of oxycodone — 327,100 doses of the drug — to a Port Richey Walgreens pharmacy, prompting a distribution manager to ask: “How can they even house this many bottles?”

There were 53 million oxycodone prescriptions filled in 2013 by US pharmacies, according to NIDA. This translates to approximately one bottle of this addictive drug for every 6 people in the country. How was this not noticed by those responsible for monitoring narcotics prescribing in the United States?

A Boardroom Contrived Opioid Epidemic

This is the pain chart created by the “Opioid Big Pharma Industry” to support massive over-prescribing of opioids across the country to everyone who walked in to a medical treatment facility, this was an effort to increase narcotic prescribing practices in mainstream medical care–and it worked very very well! This chart became a standard treatment assessment protocol tool across the country.

Reliably red on the political map, Huntington is a West Virginia town with a 182-year-old university, a storied football team and more than 100 churches.

It’s where Will Lockwood graduated from high school. It’s where he enrolled at Marshall University. It’s where he first tried OxyContin. By the time Lockwood entered Marshall, Detroit dealers were trickling into Huntington, selling OxyContin and pills with OxyContin’s active ingredient, oxycodone.

Even though Lockwood could step out his front door and get the drug, Detroit street dealers weren’t the preferred supplier, they were in Florida.

It may have been 1,000 miles away, but to Lockwood, getting OxyContin and oxycodone from Florida’s loosely regulated pain clinics “was legal, in a sense.”

Twice a month, different “crews” from Huntington crowded into vans and headed south to Palm Beach and Broward counties, home to more than 200 pill mills, the pain clinics where anyone with a fake ache and hard cash could walk out with pills and prescriptions.

After hitting a string of clinics, the Huntington crews drove back with “around 500 to 600 pills per person,” said Lockwood.

But it wasn’t just a few hundred pills. It was tens of thousands.

And it wasn’t just Huntington, The West Virginia vans were part of a nationwide caravan heading to South Florida. Cars bearing tags from Kentucky, Tennessee, the Carolinas, Virginia and Ohio crowded into one clinic parking lot after another, loading up on pills and prescriptions.

News stories and law enforcement focused on those “parking lot” states in Appalachia, where dealers and addicts with a tank of gas or a cheap plane ticket traveled the “Oxy Express” to Palm Beach and Broward.

But Florida’s pill pipeline reached far beyond those roadways.

By 2010, Florida was the oxycodone drug dealer of choice for drug users and dealers in the Great Lakes, Northeast and Mid-Atlantic regions as well as the Southeast, DEA records show, an area spanning virtually every state east of the Mississippi. It wasn’t just that Florida guaranteed a flow of cheap oxycodone. For 10 years, key lawmakers and agency heads repeatedly looked the other way as crooked doctors and bogus clinics flooded almost half the nation with the highly addictive drug.

In failing to crack down, Florida extended by years the amount of time highly addictive oxycodone would be available to both first-time experimenters and addicts. It gave criminals the raw materials for trafficking. It gave Will Lockwood the OxyContin needed to feed his growing habit, It paved the way for his eventual jump to heroin.

Jumping state lines

Teenage high-school wrestling buddies in New Port Richey ran oxycodone into Tennessee; they were paid with cash hidden in teddy bears. A Hillsborough County man mailed 17,000 pills to Glen Fork, W.Va., a month’s supply for every man woman and child in the tiny town.

A Boston Chinatown crime boss trafficked pills from Sunrise into Massachusetts, New York, Rhode Island and South Carolina. Wellington twins and pill mill kingpins Paul and Phil George, brothers who oversaw one of the largest operations in the country from their five Palm Beach and Broward clinics, pushing oxycodone into Kentucky, Tennessee, Ohio and South Carolina.

A husband and wife team operating out of a Forest Hill Boulevard clinic funneled pills to Delaware. At Palm Beach International Airport, two federal security agents accepted $500 a pop each time they waved through thousands of pillsbound for Connecticut and New York.

A Palm Bay man’s Puerto Rican family bought local pills destined for the working class town of Holyoke, Mass. In Rhode Island, police pulled over a Lauderhill man caught speeding through Providence. They found 903 oxycodone tablets and 56 morphine pills in the car.

Senior citizen and Tulane business graduate Joel Shumrak funneled more than 1 million pills into eastern Kentucky from his South Florida and Georgia clinics, much of it headed for street sales — an estimated 20 percent of the illicit oxycodone in the entire state.

Van loads of pill-seekers organized by “VIP buyers” traveled from Columbus, Ohio, to three Jacksonville clinics, where armed guards handled crowd control (federal indictment) and doctors generated prescriptions totaling 3.2 million pills in six months. In Miami, Vinny Colangelo created 1,500 internet website names to entice drug users throughout the nation to one of his six South Florida pain clinics or pharmacies.

Even the Mafia got in on the Florida oxy express action: A Bonanno crime family associate oversaw a local crew stocking up on Palm Beach and Broward pain clinic oxycodone, upstreaming profits to the New York family.

At times, it seemed almost no section of the country was free of Florida-supplied pills: When Olubenga Badamosi was arrested driving his Bentley Continental in Miami in 2011, the Oregon man was one of two traffickers overseeing a crew smuggling South Florida oxycodone to sell in Salt Lake City, Seattle and Denver as well as Oregon, Nevada, Texas and even Alaska.

Pharmacy delivers oxy ‘pot of gold’

It would be hard to overstate Florida’s role in feeding the country’s voracious appetite for oxycodone. Oxycodone 30-milligram tablets were favored by addicts. And in 2009 and 2010, roughly four of every 10 of those pills were sold in Florida. Small wonder: Of the nation’s top 100 oxycodone-buying doctors, 90 were in Florida.

Pharmacies, too, ordered jaw-dropping numbers of pills from drug distributors, the middlemen between manufacturers and pharmacies.

Cardinal Health, one of the nation’s biggest distributors, sold two CVS pharmacies in Sanford a combined 3 million doses of oxycodone, flooding the town of 54,000 with an average of 250,000 oxycodone pills every month.

West of Jupiter, a Walgreens drug distribution center sold 2.2 million tablets to a single Walgreens’ pharmacy in tiny Hudson, a roughly six-month supply for each of its 12,000 residents. It shipped more than 1.1 million pills to each of two Fort Pierce Walgreens pharmacies. By contrast, a single Walgreens pharmacy in the Central Florida townOviedo bought 169,700 doses of oxycodone in 30 days.

Why Pharmacies are LIABLE

In Fort Pierce, a Walgreens pharmacist accidentally provided an extra 120 oxycodone pills to a customer. When the druggist called to ask that the man return the pills, the customer’s girlfriend bluntly responded that he was an addict, that he sold oxycodone and the 120 pills were “a pot of gold,” DEA records show.

That was in September. The same man came back to the same Walgreens in December and January with a prescription in hand, and the pharmacy filled his prescriptions every time.

‘Wild West of Oxycodone Prescribing’

It sold to other customers in other states. But mostly, it sold to Florida: Oxycodone made up more than 60 percent of its drug sales in 2009 and 2010, according to federal records. Of its top 55 oxycodone customers, 44 were in Florida.

Company CEO Dennis Smith worried that the Florida-bound oxycodone was getting in the wrong hands. A trip to Broward did nothing to ease his mind. “It was,” he later testified, “the Wild West of oxycodone prescribing.”

Bus and park benches touted pain clinics. When Smith picked up and thumbed through City Beat, a free magazine, he found pages of ads for pain clinics. “It would show young people sitting around a pool and it named the pain clinic and say (sic) ‘we dispense on site,’ and that really hit home hard.”

Smith stopped selling to pain clinics. But the company continued to shovel millions of oxycodone pills to Florida pharmacies. Masters executives figured the pharmacies would keep an eye out for excessive prescriptions written by pill mill doctors. But not all pharmacies were worrying about doctors at pain clinics, many pharmacies were courting the pill mills prescribers.

A Lake Worth Family Pharmacy

In 2009, the small pharmacy off Lucerne Avenue in Lake Worth had a history. It had been in business for 43 years. The owner and head pharmacist had been there for 32. It had shaded parking and a downtown location, a stone’s throw from the City Hall Annex.

When a Masters inspector visited, he was alarmed to find Tru-Valu Drugs bustling with a long line of young, thin, tattooed customers arriving in groups of 10 to pick up pills. There were signs in the pharmacy warning of limits on the number of oxycodone pills handed out. Even Mallinckrodt Pharmaceuticals, an oxycodone manufacturer, was worried about the volume of its pill sales there.

Of the 300,000 doses of all drugs the small pharmacy dispensed in December 2008, 192,000 were for oxycodone 30 mg, the dosage preferred by traffickers and users alike.

And, despite the torrent of oxycodone going out the door, the pharmacy owner expressed frustration that drug distributors were limiting the amount of narcotics they would sell to his now-closed pharmacy.

Ohio to Florida and Back

Pharmacy after pharmacy benefited from the combination of Masters’ Ohio oxycodone business and Florida’s unregulated pill mills.

In Englewood, north of Fort Myers, the pharmacy owner filled prescriptions for six pain clinics — including clinics an hour’s drive away. A Masters inspector found cars from Tennessee and Kentucky in the parking lot and young men leaving the pharmacy carrying large trash bags.

Superior Pharmacy not only filled oxycodone prescriptions for pain clinics, it shared waiting room space with a pain clinic in a Temple Terrace strip mall outside Tampa. Neither Masters nor Superior had so much as Googled the background of pain clinic doctors writing those prescriptions, the DEA later said.
Had they done so, the DEA dryly noted, they “would likely have come across a press release” announcing one of the doctors had been arrested and charged with trafficking in prescription drugs.

Hundreds of thousands of oxycodone pills were sent from Ohio distributors to Florida pharmacies. Unknown thousands of pills headed right back up to Ohio.

When Ohio police burst into Christopher Thompson’s home outside Columbus, they found an assault rifle, $80,000 in cash and oxycodone from his Florida deals. A construction worker whose own pill habit started at age 14, Thompson oversaw a ring of 15 Ohio buyers who traveled to Florida to pick up oxycodone to resell in Central Ohio.

Two hours to the west in Martin’s Ferry, David L. Kidd orchestrated a ring of buyers traveling to West Palm Beach and Central Florida to pick up oxycodone for resale on the streets of eastern Ohio and West Virginia.

Driving To Pick Up Death By Rx

With more drugs came more deaths, in January 2010, say police, Fort Lauderdale pathologist Dr. Lynn Averill started a seven-month oxycodone shopping spree, buying 437,880 oxycodone pills from drug distributors.

The same month, Matthew Koutouzis drove from Toms River, N.J., to see Averill in her Broward County pain clinic. The 26-year-old collected prescriptions for 390 pills and overdosed two days later. Brian Moore traveled 13 hours from his Laurel County, Ky., home to see Averill. He left with prescriptions for 600 pills and also overdosed within 48 hours.

Kenneth Hammond didn’t make it back to his Knoxville, Tenn., home. He had a seizure after picking up prescriptions for 540 pills and died in an Ocala gas station parking lot.

Keith Konkol didn’t make it back to Tennessee, either. His body was dumped on the side of a remote South Carolina road after he overdosed in the back seat of a car the same day of his clinic visit. He had collected eight prescriptions totaling 720 doses of oxycodone, methadone, Soma and Xanax. Konkol had every reason to believe he would get those prescriptions: In three previous visits to the Plantation clinic, he had picked up prescriptions for 1,890 pills.

An estimated 60 percent of her patients were from out of state, a former medical assistant told the DEA. In 2015, Averill pleaded not guilty to eight manslaughter charges. She is awaiting trial in Broward County. Averill was just one doctor at just one clinic. In 2010, the year Averill’s patients overdosed, Florida received applications to open 1,026 more pain clinics.

An online message board advising drug users summed it up: “Just go anywhere in South Florida and look for a ‘pain management clinic.’ It shouldn’t be too hard; you can’t swing a dead cat without hitting one.” Complain about anything from a back injury to a hangnail, it advised, “and they’ll set you right up.”

By this time, Kentucky had reined in its pill mills. It didn’t matter, Ohio, Delaware, North Carolina, Connecticut acted as well, but other state’s efforts didn’t matter either, Florida continued ignoring the pill mills and rogue doctors feeding the nation’s oxycodone habit, the pills flowed.

“There were folks down there, where if I had an opportunity to, get my hands around their throat, I would have wrung their neck,” said Huntington Mayor Steve Williams. On Florida’s inaction he stated, “There was total evidence as to what was happening. It lays at the foot, in my opinion, of the public officials there that allowed it to continue on.”

Governor Jeb Bush Backed A Solution

One of the first dinners Florida Gov. Jeb Bush hosted after moving into the governor’s mansion in 1999 was a small one. Among those sitting at the table with Bush were Lt. Gov. Toni Jennings, state Sen. Locke Burt and James McDonough, who would become the state’s hard-nosed drug czar. There was an urgent topic on the agenda that night: the explosion of prescription painkillers. For the state’s first family, it may have been personal. Bush had talked publicly about one of his children’s struggle with addiction.

By the time the meal ended, all had agreed on the need for establishing a prescription drug monitoring program that would collect information and track prescriptions written for controlled substances, such as oxycodone.

Absent a prescription drug monitoring database, there was no way to know whether someone was “doctor shopping,” going from doctor to doctor, getting more and more prescriptions to feed their habit.

And there was no way to know whether a doctor was overprescribing, key to pinpointing whether a pill mill was operating, and where. Similar databases had been adopted by more than a dozen states. It was being described as a “silver bullet” to curb overprescribing. Soon enough, $2 million to get the database up and running would be on the table — but it came with a catch.

Florida Attorney General Misfires Against Purdue

In 2001, OxyContin-maker Purdue Pharma was fending off early criticism of its blockbuster painkiller. At issue was whether Purdue’s aggressive marketing campaign had misled doctors and patients alike. Purdue and three top executives later pleaded guilty to federal charges of illegally marketing the drug. Far from being safe and non-addictive, OxyContin carried the same addiction risk as morphine, and was every bit as potent.

But that was six years away. In 2001, towns in Maine reported an alarming uptick in crime tied to OxyContin. The first of several congressional hearings was ramping up. Critics and parents who lost children were piling on. Reporters were starting to write stories.

In November, Florida Attorney General Bob Butterworth appeared poised to take on the company. Calling OxyContin street sales “a major threat to public health,” Butterworth told a state Board of Medicine committee that Purdue should consider temporarily taking the drug off the market. It wasn’t only traffickers concerning Butterworth. It was the sales pitch.

In late 2001, Butterworth called a young assistant attorney general into his office and gave him a magazine article on OxyContin and an assignment: Look into Purdue marketing. Former Florida Attorney General Bob Butterworth and Palm Beach County State Attorney Dave Aronberg. The young lawyer, now-Palm Beach County State Attorney Dave Aronberg, said he knew nothing about OxyContin. But he didn’t like what he read.

During the yearlong inquiry, 589 Floridians died after taking oxycodone. Nothing criminal was found, Aronberg later said. Instead, Butterworth and Purdue struck a settlement. As part of a $2 million deal, Purdue would pay to establish a prescription monitoring database, the same silver bullet sought by Bush. After Florida’s computerized system was up and running, the same system would be free to any other state. The entire country, not just Florida, would benefit.

It could have been a groundbreaking deal. There was one catch. State lawmakers had to vote to create the prescription monitoring program by 2004, or Purdue would keep its money.

Marco Rubio Kills The Anti-Oxy Rx Bill

A political gight killed the program. “And there was one person who was responsible,” said former state Sen. Burt, now an Ormond Beach insurance executive. “And it was Marco Rubio.”

A rising state lawmaker in 2002, now-U.S. Sen. Marco Rubio had the clout to make or break the legislation. He had been one of two state House majority whips and was on the fast track to becoming House speaker.

Rubio didn’t kill the 2002 bill out of opposition to prescription monitoring—it was politics “as usual” yet nobody blamed Rubio for the resulting opioid crisis that seems to have started in his political backyard and flourished beyond belief..

U.S. Sen. Marco Rubio, R-Fla., was a leader in the Florida House in 2002 when he blocked a vote on prescription monitoring. That year, Rubio favored a bill changing the Miami-Dade County charter, which failed to pass because of a single “no” vote in the Senate. Burt cast the vote.

Angered by what he saw as Burt’s betrayal, Rubio killed the prescription drug monitoring bill. “When I found out he broke his word, it made the choice easy,” Rubio told The Miami Herald.

It’s not certain that the full Legislature would have passed the bill had it made it to a floor vote. Rubio was the first, not the last, in a line of state legislative leaders over years who would refuse to seriously consider the bill. Most cited privacy concerns.

But prescription monitoring databases in Florida and other states free to use Florida’s model would have pinpointed rogue doctors, would-be pill mills and doctor-shoppers across the country, just as all three were beginning to converge. In doing so, it could have curbed a national opioid epidemic when it was just an emerging problem, not the monster it would become.

Only weeks after the 2002 bill was killed, Bush suppressed a sob as he discussed his daughter’s arrest for forging a prescription. Court-ordered to drug treatment and then briefly to jail, Noelle Bush survived her pill addiction. The 2004 deadline for greenlighting a monitoring system passed. So did Purdue’s million-dollar obligation to pay for it.

Between 2002, the year Rubio killed the database that could have identified doctor-shoppers, and late 2011, when the database finally came online, more than 20,800 Floridians died after taking prescription opioids, including OxyContin, annual Florida Medical Examiners’ reports show. “Not getting that bill through the Legislature resulted in Florida becoming the pill mill capital of the United States,” said Burt.

“There was heartache for thousands of families beyond measure and it didn’t have to happen.”

Florida Officials Were Told Of The Oxy Express

The East Kentucky hills and valleys of Greenup County suit Keith Cooper, a long-haired undercover cop-turned-sheriff: “It’s a backwater. I tell people all the time I am a hick sheriff from a hick location, and by 2011, the rural county and its sheriff had big city problems.

Greenup is near the stretch of interstate highways that provided drug traffickers and users with a straight shot to Palm Beach and Broward pill mills. It’s less than an hour’s ride to Huntington Tri-State Airport, where a $27 flight to Fort Lauderdale was a popular draw for dealers hoping to stock up.
Arrests for Florida pills soon eclipsed local arrests for pot.

“When we locked ’em up, we take all their pill bottles and all their paperwork, and we found maps to the doctors offices and everything,” recalled Cooper.
“I called the (Florida) medical board and gave them a big list of doctors,” Cooper said. He called the state pharmacy board, too. He got no response.

“So then I called the Attorney General’s Office and the Governor’s Office. I was calling them all, the whole state. Of course, I was talking to the state police the entire time. “I told them, all of the profits were down there. And all of the pain’s up here.” Nothing happened. Florida’s oxycodone pipeline continued to flow.

On the other side of the law in Greenup, Mikey Frazier was banking on it.

The Oxy Express

Frazier was on a scholarship to play baseball at his junior college in Chicago when he suffered a torn rotator cuff. Doctors prescribed Percocet, a pill containing oxycodone, in 2002. When doctors cut him off, he bought it on the street. In 2006, he moved to OxyContin, nearly pure oxycodone. In 2007, he gave his friends money to go to Florida and bring him back pills.

“My buddy had a minivan and he would actually go down one week and take two to three people with him, and then the following week I’d go,” said Frazier. He still remembers the route: “I’d take 64 East to 77 South to 95 South. And it’s just a straight shot.”

Others followed suit. “What got everyone started was because the doctors around here won’t write a strong enough prescription,” he recalled. OxyContin and generic oxycodone still could be had — just not in Kentucky, which had a prescription drug monitoring database.

In Florida, “there was none of that … stuff that they check and find out what doctor you’ve been to,” said Frazier.

“And one person does it, and then they tell a friend, and then they go do it, and that’s how it all really got started here.”

MEDICAID-MEDICAIRE PAID MILLIONS FOR OXY

Tallahassee wasn’t just ignoring the epidemic, It was financing it.

Before her office was raided by law enforcement in December 2001, Asuncion M. Luyao’s patients would wait in a line in the rain to get prescriptions from the Port St. Lucie internist and acupuncturist. She was one of the most prolific prescribers of OxyContin in the state.

And hundreds of thousands of those pills were being paid for by Medicaid, Florida’s taxpayer-financed health program for the state’s poorest and sickest citizens. Between 1999 and 2001, Medicaid shelled out $935,634 for OxyContin prescriptions written by Luyao. That was just OxyContin. Luyao was prescribing an array of addictive drugs. In the 12 months leading up to the clinic raid, Medicaid paid roughly $1 million for 7,000 prescriptions, only about 17 percent of them for OxyContin.

Nor did the raid slow her down. Between the raid and her arrest on trafficking charges four months later, Luyao wrote another 282 OxyContin prescriptions billed to Medicaid. She was not an outlier. In 24 months, taxpayers footed the bill for more than 49 million doses of pills containing oxycodone, even though there were only 1.36 million Medicaid patients. Half were children.

The sheer volume of pills might have been a tipoff that the drugs were not all intended for legitimate use. So were arrest reports dating to 2001. One man had used his 7-year-old son’s Medicaid number to doctor-shop for OxyContin. A Miramar pharmacist who billed Medicaid $3.7 million for OxyContin pills was charged with paying Medicaid patients $150 each to use their IDs.

Medicaid paid for more than $300,000 to fill Dr. James Graves’ OxyContin prescriptions. The Florida Panhandle physician was the first doctor in the nation convicted of killing patients by overprescribing OxyContin.

Addiction risk for people taking high doses of oxycodone begins climbing after just three days, a recent study concluded. And most people on Florida Medicaid getting oxycodone prescriptions in 2011 were getting much more than a few days worth. They were getting an average of nine months worth of pills, state officials said.

Pill mill doctors prescribed 1 million of those pills:

Doctors working for the George twins’ trafficking empire prescribed at least 102,081 oxycodone pills billed to Medicaid before the ring collapsed in 2010.

Working out of a Delray Beach pain clinic founded by a convicted drug smuggler, Zvi Harry Perper, son of the Broward County medical examiner, was arrested on trafficking charges, but not before he wrote prescriptions to Medicaid patients for 115,977 doses of oxycodone in 90 days.

In Lake Worth, Cesar Deleon was arrestedas part of a DEA pill mill sweep and charged with 55 counts of illegally distributing drugs. Deleon wrote orders for 20,302 oxycodone pills for Medicaid patients.

Miami internist Dr. Selwyn Carrington authorized 32,411 doses of oxycodone for Medicaid patients in just two years. He was busted for signing his name to hundreds of prescriptions.

Further, Florida wasn’t in any hurry to stop doctors linked to pill mills.

Perper was busted at a Delray Beach pill mill operated by a former felon in 2011. The state did not act against his license until 2014.

Joseph M. Hernandez was writing prescriptions from his car, a veritable pill mill on wheels, when he was busted in February 2010 on one count of trafficking in oxycodone.

.Florida’s Department of Health didn’t file paperwork to restrict his license for almost 18 months.

During that time, Hernandez wrote oxycodone prescriptions for Medicaid patients totaling 258,940 doses representing a taxpayer-footed bill of $130,165.

Purdue Pharma’s Profits Before Patients Creed

Kelly Skidmore is exactly the type of person Purdue Pharma’s OxyContin marketing was intended to reach: Diagnosed with juvenile arthritis, the former state legislator’s struggle with chronic pain began at age 4.

Skidmore was wary of opioid painkillers, though, one reason her willingness in 2009 to work with Purdue was surprising. But she did it to get Florida’s dormant drug monitoring database up and running.

Then a state representative in a district straddling Palm Beach and Broward counties, Skidmore recalled that, “They came to me and said, ‘Could you help get it across the finish line?’ ”

OxyContin and prescription opioids, a serious problem in 2002, had evolved into a full-blown crisis in the ensuing seven years. Broward alone had more pain clinics than it had McDonald’s. Deaths tied to oxycodone had exploded, up by 263 percent since the prescription monitoring database had first been proposed and killed. Overdoses from prescription opioids were claiming more than seven lives a day.

“By God, if we had had seven dolphins a day dying and washing up on Florida beaches, we would have been appropriating money and solving it,” Skidmore said.

Skidmore believed a database wasn’t going to resolve the underlying addiction crisis. Still, it was a start. Not a silver bullet, but “maybe silver buckshot,” she said. The database law passed with gaping loopholes. No health care professional would have to report opioid prescriptions or check the database before prescribing more, and the state refused to pay for it.

“Just to get that one little piece … took nine years of filing bills and then it had no teeth,” Skidmore said. “And it should have been the easiest piece.”

Where Was The DEA and Everyone Else?

The DEA all but wrung its hands over Florida’s lethal inaction. The agency ticked off a devil’s brew of regulatory loopholes: Florida’s Health Department regulated health care professionals but not pain clinics. The state’s Agency for Health Care Administration regulated pain clinics that accepted insurance, but pill mills were most often on a cash-only basis. And the prescription monitoring database, mired in a vendor dispute, remained stalled.

In early 2011, when Gov. Rick Scott took office, just one drug — oxycodone — was tied to six fatal overdoses a day. Deaths tied to all drugs claimed 25 a day. In the handful of Appalachian states where traffickers were bringing back South Florida pills, it was worse.

Ohio’s death rate for oxycodone and similar opioids had doubled in 24 months, federal records show. Kentucky’s was up by more than 50 percent. And in West Virginia, home to hard-hit Huntington, death rates tied to pill mill drugs such as oxycodone and Opana had climbed by 341 percent.

The DEA formally pinpointed Palm Beach, Broward and Miami-Dade counties as the nation’s single biggest hub for trafficking pills across state lines. Within weeks of being sworn in, Scott abolished Florida’s Office of Drug Control, eliminating the state drug czar position, announced plans to drive a final stake in the heart of the database and rebuffed Purdue Pharma’s renewed offer to help pay for it.

Scott, a tea party conservative, cited privacy concerns, expressed skepticism the monitoring program would work and raised the possibility taxpayers would be left with a $500,000-a-year bill to operate it.

Attorney General Pam Bondi had also ridden the tea party wave to her position. She shared many of Scott’s conservative convictions. Unlike Scott, the former prosecutor relentlessly lobbied to keep the database alive. Florida’s failure to adopt the drug monitoring database was so out of step with the rest of the country that it began spawning conspiracy theories on both sides of the law.

Everyone knew prescription monitoring was going to kill the pill smuggling business, said a corrupt Florida Highway Patrol trooper as he drove a load of pills out of Florida, according to a federal lawsuit. Talking to the confidential informant in the seat next to him, the trooper speculated someone in Tallahassee must have a piece of the action, “because (Scott) was so adamant about not putting that system in place. Right?”

In Greenup, an infuriated Cooper told a reporter, “In my opinion, (Scott’s) getting money from somewhere. He has to be.” A few days later, recalled Cooper, “A lieutenant with the state police I’d been talking to down there called me, said, ‘Man, just a head’s up: I wouldn’t come to Florida.’” In states on the receiving end of the Florida pill pipeline and among federal officials, Scott’s resistance triggered outrage.

In Kentucky, where as much as 60 percent of the illicit oxycodone in that state flowed from Florida, Lt. Gov. Daniel Mongiardo proposed erecting billboards at the Florida line: “Welcome to the Oxy Tourism Capital of the World.”

U.S. House Appropriations Chairman Hal Rogers, also from Kentucky, twice wrote Scott. “Canceling Florida’s prescription drug monitoring program is equal to firing firefighters while your house is ablaze,” he wrote.

Gil Kerlikowske, director of the White House Office of National Drug Control Policy, asked to meet with Scott. So did DEA Administrator Michele Leonhart.

Three U.S. senators — New York’s Chuck Schumer, West Virginia’s Joe Manchin and Rhode Island’s Sheldon Whitehouse — joined Florida’s Bill Nelson in pointing out that the pills weren’t just a Florida problem: There were “serious ramifications for the rest of the country,” wrote Nelson of Scott’s reluctance to crack down. This is a perfect example of how political rhetoric, in-fighting and contrived agendas prevented an early stop to the emerging opioid crisis many years ago.

WHY DIDN’T THE DEA, DRUG DISTRIBUTORS AND PHARMACIES TAKE NOTICE BEFORE THE OPIOID CRISIS SPREAD ACROSS THE COUNTRY LIKE WILDFIRE? WAS IT BECAUSE OF THE BILLIONS IN PROFITS, QUARTERLY BONUSES AND DIVIDENDS? STOCK OPTIONS CASHED IN BY BOARDROOMS AT EVERY OPIOID BIG PHARMA COMPANY? STAY TUNED FOR HOW “PROFITS BEFORE PATIENTS” BECAME THE NORM

(article excerpts and quotes have been taken from publicly available media sources and court records)

The hernia mesh products at issue were manufactured by C.R. Bard, Inc. and its subsidiary, Davol, Inc., which control close to 70 percent of the U.S. hernia mesh implant market. There are close to 100 hernia mesh lawsuits currently pending against C.R. Bard and Davol in federal courts around the country, which is expected to increase drastically upon formal consolidation into MDL 2846.. All claims involve injuries allegedly related to the companies’ polypropylene hernia mesh implants, including the Ventralex and Perfix devices and several others, the product pool encompasses almost all Bard/Davol polypropylene hernia mesh products. Plaintiffs allege that the devices were defectively designed and caused extensive long term complications, debilitating post-surgery injuries and adverse reactions.

The motion, also supported by Bard/Davol, has proposed the U.S. District Court Southern District of Ohio, or alternatively, the Western District of Missouri, as possible venues for the multidistrict litigation. Bard alternatively requested the MDL be transferred to U.S. District Court in New Jersey or the Southern District of New York.

Ms. Stokes commented: “We represent hundreds of clients that have been seriously injured by hernia mesh products manufactured by Davol/C.R. Bard. We have observed that these devastating injuries are occurring all across the United States. Because of this widespread harm, we moved for coordination and consolidation under Section 1407. We believe the suggested venues offer convenience to all parties and have docket conditions that are conducive to the most efficient path to a fair and just resolution for our clients.”

Ms. Stokes added, “Considering Davol/CR Bard is the market leader for products used in the most commonly performed surgery in the United States, this MDL has the potential to be one of the largest medical device MDLs ever. The number of cases could very well reach into the hundreds of thousands.”

Adam Evans clarified the role of revision surgeries in determining eligibility to file a claim: “Having undergone a revision surgery is not a precondition to filing a case. Nor does a revision surgery, in itself, give rise to a viable case. The question of whether or not a person has undergone a revision surgery presents a sort of false dichotomy as we evaluate these cases. All that is necessary to file a case is that a plaintiff has suffered an injury, which evidence indicates was caused by a defect in the product. A revision surgery often provides us with the evidence with which we can connect the injury with the product defect, but there are oftentimes other sources of evidence that a defective product has caused an injury.

For example, treating physicians can conduct imaging studies, nerve conduction studies, and other types of tests, the results of which would permit them to conclude that the product is causing the symptoms of which the plaintiff complains. On the other hand, regarding revision surgeries, a second surgical prodedure may result in findings that rule out the product defects as a cause of the patient’s symptoms. In the end, a medical determination that the plaintiff has been injured by the mesh in some way is generally necessary in order to justify filing.”

Both Ms. Stokes and Mr. Evans are available to discuss the Bard MDL, as well as any other questions or concerns you may have regarding hernia mesh issues in general. The list of Bard/Davol products sought to be included in MDL 2846 is fairly significant and covers almost all of the Bard polypropylene hernia mesh products.

BARD MDL 2846 POLYPROPYLENE HERNIA MESH PRODUCTS

Composix

Composix E/X

Composix L/P

Ventralight

Spermatex

Sepramesh

Ventralex

Ventralex ST

Kugel Patch

Composix Kugel

Ventrio

Visilex

Ventrio ST

Marlex (AKA Flat Mesh; Bard Mesh)

Perfix Plug

Perfix Light Plug

3D Max Light

3D Max

COMMON INJURIES

Many of the complications associated with hernia repair involving mesh are multi-factorial, and any case must undergo in-depth analysis to ascertain whether the defects of a hernia mesh played a role in the complications. Here are some of the injuries which patients throughout the country are reporting following implantation of one of these hernia mesh products:

Mesh infection

Chronic, debilitating pain

Mesh migration

Mesh contracture

Hernia recurrence (as a result of migration and/or contracture)

Mesh rupture (aka “mechanical failure”)

Wound dehiscence

Fistula or sinus tract formation

Adhesions of mesh to bowel

Bowel perforation

Bowel obstruction (as a result of adhesions)

There are many other types of adverse health effects which can stem from these complications, and research is ongoing as to the direct relationship between polypropylene mesh implants and other conditions such as auto-immune disorders.

Joshua S. Kincannon, Lomurro Law Firm in Freehold, New Jersey is counsel in another emerging hernia mesh litigation, the Ethicon “Multi-Layered Hernia Mesh” Litigation, which is the subject of a pending MCL application in New Jersey State Court. Mr. Kincannon stated in support of the Bard MDL 2846: “For decades, medical device manufacturers have utilized polymers that are not safe or effective for permanent implantation in the human body. The hernia mesh litigation is just another example of what happens when there is little to no oversight into how these products are designed, manufactured and sold to the public.”

The moving plaintiffs are represented by Kelsey L. Stokes and George M. Fleming of Fleming, Nolen & Jez in Houston; Adam M. Evans and C. Brett Vaughn of the Hollis Law Firm in Prairie Village, Kansas; Troy A. Brenes of the Brenes Law Group in Aliso Viejo, Calif.; and Steven C. Babin Jr. of the Chapin Legal Group in Columbus, Ohio.

“THE OPIOID CRISIS IS NOW PART OF URBAN AMERICA AND BIG CITY LIFE”

Mark A. York (July 12, 2018)

Trash left by drug users under bridge in Philadelphia. (Washington Post image)

(MASS TORT NEXUS MEDIA) According to sources at all levels from police and fire first responders to emergency room physicians across the country and analysts at the CDC, there’s been no slowdown in opiate based medical emergencies in the US over the last 2 years. Emergency response and ER visits for opioid overdoses went way up, with a 30 percent increase in the single year period of June of 2016 to June of 2017, according to the Centers for Disease Control and Prevention. This is now much more common in big city and urban areas of the country that it was just four years ago.

Center for Disease Control’s Acting Director Dr. Anne Schuchat said overall the most dramatic increases were in the Midwest, where emergency visits went up 70 percent in all ages over 25. The affected populations and demographics are comparative to prior medical crisis deaths during historical healthcare pandemics when a disase struck across entire populations, while sparing no particular class of society.

WHY THE HUGE INCREASE IN THE MIDWEST?

ER visits for opioid-related emergencies more than doubled in two states. Wisconsin saw the biggest increase, 109 percent and Delaware saw a 105 percent increase. In Pennsylvania, ER visits were up 81 percent.

“We’re seeing the highest ever death rates in the US,” Schuchat said. She pointed to national statistics that out of 63,000 overdose deaths in 2016, 42,000 of them involved opioids.

“[This] means 115 people die each day from opioid overdose,” she said. This number has been at or above 100 for most of the last 3 years, with no end in sight and with so many different regions affected it may require more grassroots focus and demands made to elected officials to move faster on a long term solution.

There were some decreases reported in the East, with the largest being a 15 percent reduction in Kentucky, which could reflect fluctuation in drug supplies or interventions.

However, hospital visits in cities of all types increased steadily in each quarter by 51 percent. Schuchat emphasized, “Bottom line — no area of the US is exempt from this epidemic.” Looking closer at causation and access to opiates across the country is required. How are unlimited numbers of federally controlled substances still so readily accessible to so many?

US Surgeon General James Adams was also present during the briefing and mentioned how he witnessed first-hand his own young brother’s struggle with opioid addiction.

“Science is clear: Addiction is a chronic disease and not a moral failing,” the doctor said. Adams outlined that a coordinated effort is necessary to prevent opioid addiction. “To successfully combat this epidemic, everyone must play a role,” he noted.

The Surgeon General explained how health departments, along with public safety and law enforcement officials, have to work together to deal with local opioid-related emergencies.

He stressed the need to make naloxone, a life-saving drug that can reverse the effects of an overdose, more accessible in emergency situations.

URBAN AMERICA AND OPIODS

The CDC data shows trends in opioid overdose emergency room

In late 2016 through current medical data from the CDC and hospitals across the country, the opioid epidemic is fast becoming a big city problem.

There was a 54 percent increase in overdoses from July 2016 through September 2017 in the major metro areas of 16 states surveyed by the federal Centers for Disease Control and Prevention — a chunk of the country that includes Chicago, Philadelphia, Milwaukee, Cleveland and Columbus, Ohio.

Nationwide, the scourge that President Donald Trump has vowed to defeat shows no sign of abating, with a 30 percent increase in opioid overdoses reported during that same period, the data released Tuesday shows.

Anne Schuchat, the CDC’s acting director, said the grim new arithmetic, which came from emergency room statistics, confirmed some suspicions. “We’re currently seeing the highest drug overdose death rates ever recorded in the United States,” Schuchat said in a Q&A session with reporters. Asked specifically about the rise in urban opioid overdoses, Schuchat said health officials suspect a “change in the toxicity” of drugs on the street.

Urban heroin dealers have been boosting profits by cutting their drugs with fentanyl, which is 25 to 50 times more powerful. That combination was why Columbus was averaging one fatal overdose per day in the first half of last year.

“The issue of cutting heroin with fentanyl is a very major problem right now,” Schuchat said. “What you are seeing in Columbus is for sure occurring in other

“But the recent rises are mostly driven by heroin, and particularly fentanyl, and the latter seems particularly prevalent in urban drug markets,” said Raymond, whose organization is based in New York City. “That’s certainly true in places like Ohio and Philadelphia, which are seeing a lot of fentanyl-involved overdose deaths. That doesn’t mean the problems have waned in smaller cities and rural areas, which are also seeing fentanyl, but we are seeing increasing vulnerability in major urban centers.”

The only bright spot — and it’s a dim one at that — was that the CDC found decreases in opioid overdoses in states like West Virginia, New Hampshire and Kentucky that have been leading the nation in the category.

“We hope this is a positive sign,” said Schuchat, who credited leadership, particularly in West Virginia, with taking bold steps to combat the crisis. “But we have to be cautious in the areas that have reported decreases.” Dr. Rahul Gupta, Director of Public Health for West Virginia has been at the forefront of addressing the opioid crisis in not only West Virginia but across the country. Dr. Gupta will be the keynote speaker at the Mass Tort Nexus National “Opioid Crisis Summit, July 20-22, 2018 in Fort Lauderdale, FL where he will be joining other prominent national healthcare and legal speakers on providing solutions to the opioid crisis, see www.opioidcrisissummit.comfor attendance information.

“Sometimes places that have had such high rates have no place to go” but down, she added, with West Virginia being one of the states to address the issues pro-actively in all areas.

The new CDC “Vital Signs” report was released a week after Attorney General Jeff Sessions issued a “statement of interest” in support of local governments that are suing the big pharmaceutical makers and distributors, accusing them of swamping many states with prescription painkillers and turning millions of Americans into junkies.

The new CDC numbers come from analysis of emergency room data from 16 states, including some hardest hit by the plague — Delaware, Illinois, Indiana, Kentucky, Massachusetts, Maine, Missouri, Nevada, New Hampshire, New Mexico, North Carolina, Ohio, Pennsylvania, Rhode Island, West Virginia and Wisconsin.

Is Fentanyl The New Crack Cocaine?

The Centers for Disease Control and Prevention issued a Health Alert Network warning about the increased supply of the illicit drugs, which are many times stronger than fentanyl, the prescription painkiller.

“The dramatic rise in the supply of illicitly manufactured fentanyl and fentanyl analogs has been mirrored by an equally dramatic rise in deaths involving synthetic opioids other than methadone, a category which includes fentanyl and fentanyl analogs,” the CDC said in its alert.

Death rates doubled between 2015 and 2016, the CDC said. “More than 55 percent of opioid overdose deaths occurring nationally in the 12 months ending November 2017 involved synthetic opioids, accounting for more than 27,000 overdose deaths,” the CDC said in the health alert, citing preliminary numbers.

That’s up from 20,000 overdose deaths from synthetic opioids in 2016.

Other illicit synthetic opioids include furanylfentanyl and acrylfentanyl. “Finally, drug submissions testing positive for a synthetic illicit opioid known as U-47700, first encountered by the DEA in 2016, increased from 533 submissions in 2016 to 1,087 during January–June, 2017,” the CDC said in the alert, referring to the Drug Enforcement Administration.

What Is Fentanyl?

Fentanyl, a schedule II prescription narcotic analgesic, is roughly 50-80 times more potent than morphine. This medication is used to manage both pain during surgery and chronic moderate to severe pain for persons who already are physically tolerant to opiates. • However, fentanyl also can be produced in clandestine laboratories in powder form and mixed with or substituted for heroin.

“Ohio alone reported more than 1,700 opioid overdose deaths testing positive for fentanyl analogs during July 2016–June 2017, with more than 1,100 of those deaths involving carfentanil.”

Emergency responders and physicians may not know that people overdosing on the synthetics may need extra care, the CDC said.

ANOTHER J&J BABY POWDER OVARIAN CANCER TRIAL

Johnson & Johnson is flying solo in their latest baby powder cancer trial underway in St. Louis City Circuit Court, in front of Judge Rex Burlison, who has refused the many attempt by J&J to dismiss, remove and simply evade another ovarian cancer trial linked to J&J’s baby powder. This time they’re standing alone, after co-defendant Imerys Talc settled claims with 22 plaintiffs right before the trial began. The US unit of French minerals company Imerys SA settled claims by women for at least $5 million, related to Imerys mined talc supplied to Johnson & Johnson for making baby powder that’s been linked to ovarian cancer in several previous trials across the country.

The question becomes, just when did J&J become aware of the many adverse events and dangers of using its baby focused Talcum Powder products that have also been used by millions of adults worldwide?

At the start of the trial, plaintiff trial attorney Mark Lanier told jurors about a study of infants who had been born dead. “They took biopsies and all of them had asbestos that had migrated from the womb across the placenta.”

Then Lanier showed the jury an internal J&J email where someone at the company recommended moving the product from the baby aisle or replacing talcum with corn starch.

Lanier has stated he’s uncovered stacks of new evidence showing J&J officials knew by the 1960s its baby powder was tainted with at least trace amounts of asbestos and hid the product’s cancer risks to protect its reputation.

Why would Johnson & Johnson be sending internal e-mails of this type, if there weren’t known risks associated with the talc products?

J&J USE OF FRONT COMPANIES AND LOBBYING GROUPS

With J&J at the helm, the Cosmetic Toiletry and Fragrance Association (CTFA), now the PCPC, formed a talc lobbyist group in response to the first epidemiologic studies that discovered an association between ovarian cancer and genital talc use in the early 1980s. J&J and Luzenac, now Imerys Talc, were the primary actors and contributors to the Talc Interested Party Task Force (TIPTF). J&J and Imerys coordinated all the activities of the talc lobbyist group in the District of Columbia.

The stated purpose of the TIPTF was to pool financial resources of primarily J&J and Imerys to collectively defend talc at all costs and prevent regulation of any type over the cosmetic ingredient. The talc lobbyist group hired scientists to perform biased talc safety research studies. Members of the lobbyist group edited research reports by scientists on their payroll prior to submitting them to governmental agencies. Furthermore, TIPTF members knowingly released false information about the safety of talc to the public and used political and economic influence on regulatory bodies to prevent any intervention.

PCPC coordinated the defense of talc and acted as a mouthpiece for TIPTF members, including J&J and Imerys. PCPC’s revenue is generated through a dues system based on its members’ annual sales. $76.5 billion in annual sales puts J&J in the top hundred of the highest grossing companies in the world, and the highest revenue generator in the PCPC. Consequently, the PCPC had an extremely vested interest in protecting J&J’s products and financial interests.

J&J SUPPRESSED ADVERSE FINDINGS ON TALC

According to scientific evidence, there have been studies showing a direct link between talcum powder and ovarian cancer that started emerging close to 50 years ago. How as this kept from public view? Starting in 1971, Dr. W.J. Henderson and other notable researchers in Cardiff, Wales conducted the first study that suggested an association between talc and ovarian cancer.

In 1982, the first epidemiological study on talc powder use in the female genital area emerged. This study found a 92 percent increased risk of developing ovarian cancer in women who reported genital talc use. Shortly after the study’s publication, Dr. Bruce Semple of J&J spoke with lead researcher Dr. Daniel Cramer. Dr. Cramer advised Dr. Semple that J&J needed to place a warning on its talcum powder products about ovarian cancer risks so that women could make informed decisions about their health. Since 1982, there have been more than 27 additional epidemiological studies indicating a significant link between talc and ovarian cancer.

In 1993, a U.S. National Toxicology Program published a study on the toxicity of non-asbestiform talc that determined that there was clear evidence of carcinogenic activity. Consequently. researchers concluded that talc was a carcinogen, with or without asbestos contamination. Then, in 1994, the Cancer Prevention Coalition notified J&J’s CEO that studies as far back as the 1960s “…show conclusively that the frequent use of talcum powder in the genital area poses a serious health risk of ovarian cancer.”

The coalition further indicated that 14,000 women die from ovarian cancer each year and that this type of cancer is very difficult to detect and has a low survival rate. The coalition begged the company to withdraw its talc products from the market or at least provide safety information.

Since then, the World Health Organization, the Canadian government, and various other cancer organizations have classified talc as a carcinogen.

The Ingham v. Johnson & Johnson Missouri Trial

The current case before Judge Burlison is at least the fifth ovarian cancer trial held in his court in the last two years. In previous trials, plaintiffs from across the country have been awarded substantial judgments totaling more than $300 million. One of the first talc trials resulted in a $72 million verdict for Jacqueline Fox, of Birmingham, AL which was vacated by a state appeals court last October, based on the US Supreme Court’s Bristol-Myers Squibb (BMS) v. Superior Court of California decision of June 2017 related to non-resident plaintiffs in state court actions.

This current case filed by Gail Ingham of O’Fallon, Mo. was removed to federal court last year by J&J, but US District Court Judge Stephen Limbaugh remanded it back to Judge Burlison’s court in July.

On May 15, 2018 Burlison told parties to get ready for trial and ruled that he would not sever, transfer or stay claims, finding sufficient contacts between Johnson & Johnson in Missouri to invoke a long arm statute.

WIDELY DIFFERENT VIEWS

Johnson & Johnson has defended lawsuits alleging its baby powder caused ovarian cancer in women in the past, as several trials across the country have linked their illnesses to exposure to asbestos in the company’s talc.

The talc cases which now number close to 10,000 in state and federal courts, with claims that the company sold talc in its iconic white Johnson’s Baby Powder bottles knowing it either caused ovarian cancer or was tainted with asbestos and failed to warn consumers to protect the brand.

A J&J representative, said in an emailed statement “The talc in Johnson’s Baby Powder does not contain asbestos or cause ovarian cancer and we will continue to defend the safety of our product,”

J&J FACING OVER 9,000 SUITS

Last month, jurors in California awarded a woman who said she routinely used talc on children and herself $25.7 million over her mesothelioma diagnosis. A South Carolina jury couldn’t reach a verdict on similar claims the same week as the California ruling.

Those decisions followed a New Jersey jury’s finding in April that J&J and a unit of talc supplier Imerys SA must pay $117 million to a banker who claimed his cancer was tied to baby powder use.

J&J still faces talc lawsuits by more than 9,000 plaintiffs, primarily focused on ovarian cancer, according to a May securities filing. That number has grown from 1,200 in 2016. An unknown number of consumers claim that J&J’s talc products caused mesothelioma. See J&J Talcum Powder MDL 2738 USDC New Jersey Briefcase.

WHEN AND WHAT DID J&J KNOW ABOUT TALC DANGERS?

In opening statements, Lanier said the “big fight” in the case was whether there’s asbestos in J&J’s talc products and whether J&J knew it and hid it.

He then offered that multiple studies by universities, companies, agencies and even J&J itself found asbestos in talc, but that J&J had “manipulated the science in more ways than I can count” to obscure the facts. The company was compelled to protect its baby powder brand as its “sacred cow,” based on the millions of dollars earned every year.

The women, whose jobs range from school bus driver to executive director of a job-retraining program, come from states across the country, such as Pennsylvania, California, Arizona and New York. Six of the women have died, so their families are pressing wrongful-death claims against J&J.

When Krystal Kim, one of the women suing, learned testing by her lawyers of the Johnson’s Baby Powder she used showed it was laced with asbestos, she felt sick. “I was scared and mad at the same time,” said Kim, a 52-year-old former computer consultant now battling ovarian cancer. “It certainly wasn’t what I expected to have in my house or to be putting on my body every day.”

Kim traveled to St. Louis for the trial and she’s banking on jurors holding J&J accountable for her cancer after hearing Lanier’s evidence. “I’m hoping this jury says no more little girls should be harmed by this powder,” she said. “I’m hoping it stops here.”

The trial is expected to last another week to 10 days and we will provide updates until a verdict is returned.

Opioid Industry Model of “Profits Before Patients” and The Impact on American Children

By Mark A. York (July 5, 2018)

(MASS TORT NEXUS MEDIA) In West Virginia, home of the highest overdose rates in the nation, the foster population has increased by 42 percent since 2014.

The number of children in state or foster care hit a record low in Massachusetts earlier this decade. Since then, that number has risen by a quarter, and there are now more children in state care than ever before.

In Ohio, the number of children in state custody has grown by 28 percent since 2015. Foster populations are up more than 30 percent in Alabama, Alaska, California, Idaho, Indiana, Minnesota and New Hampshire since 2014. states like Illinois, Oklahoma, Massachusetts, Pennsylvania, Colorado and New Jersey now adopting new approaches to help keep parents and children together, even as parents are receiving treatment for their addictions.

The opioid epidemic plaguing the nation is taking a catastrophic toll on our most vulnerable group, the children of the opiate addicts and those with substance use disorders. Many children are sent to live with grandparents or other family members, often due to a parent overdose or other addiction displays other problems but tragically, a growing number are being placed in the foster-care system, with many states unable to keep up with the demand from both a budget as well as staffing is struggling to keep up with demand.

From 2013 to 2015, the number of children in foster care nationwide jumped almost 7 percent to nearly 429,000, according to the U.S. Department of Health and Human Services’ Administration on Children and Families, the 2016 to 2018 numbers have moved that number closer to 550,000. Parental substance use was cited as a factor in about 32 percent of all foster placements. From 2000 to 2015, more than half a million people died of an overdose, and currently 91 people a day die from opiate overdoses.

Unfortunately, many children, the indirect victims of the crisis, are not getting the care and services they need. “This is a neglected subpopulation,” says John Kelly, PhD, associate professor of psychiatry in addiction medicine at Harvard Medical School, and the founder and director of the at Massachusetts General Hospital. “Because we’re trying to put out the fire in terms of stopping overdose deaths, we haven’t really been attending to other casualties, including kids most importantly.”

To lessen the long-term effects on children, psychologists are treating children in the foster-care system in outpatient, inpatient and residential treatment programs and in school-based mental health programs.

[STUDY OBJECTIVES: The prevalence of opioid use disorder (OUD) during pregnancy is increasing. Practical recommendations will help providers treat pregnant women with OUD and reduce potentially negative health consequences for mother, fetus, and child. This article summarizes the literature review conducted using the RAND/University of California, Los Angeles Appropriateness Method project completed by the US Department of Health and Human Services Substance Abuse and Mental Health Services Administration to obtain current evidence on treatment approaches for pregnant and parenting women with OUD and their infants and children]

Everett Washington Schools and Opioids

The front office at an elementary school was never intended as an intake center for drug-counseling and social-services referral hub. For 31 year old Tiffany Smith and others in Everett, it has become just that for the last two years, as she attempts to end her heroin addiction while raising three children.

Smith often chats with the office staff and updates Principal Celia O’Connor-Weaver on her progress in treatment. The first time she ventured inside, Smith carried paperwork from Child Protective Services, and needed to tell the principal that her children, who taken into foster care months before might still get visits from state social workers, even now that the kids were returned home.

Explaining all of this to the principal meant describing what led to the boys’ removal, which meant confessing that she had been addicted to opiates, at times living in her car, the kids staying at her grandmother’s house, until her grandmother finally called state authorities.

“I was afraid of the judgment, that my kids would be affected at school , but it wasn’t that way at all. They said they have a lot of parents that have gone through opiate addictions and what can we do to help? It was not what I was expecting.”

In her six years as principal at the elementary school in Everett, an epicenter of the opioid crisis in Washington, 525 Snohomish County kids were removed from addicted parents just in 2017, in Seattle’s King County, more than 1,000 children were removed.

This problem is now prevalent across the United States where schools, social service agencies and public-health workers scramble to stem adult addictions, less visible have been the reverberations downstream, the children of opioid addicts. Educators and child-welfare workers have reported increased learning problems and behavioral outbursts from the kids of addicted parents. Research suggests dire life-outcomes for these students. Yet the potential for school-based interventions has been underutilized — even as public-health investigators say schools offer the most efficient hope for stemming a looming social crisis.

During the most mundane moments, like recess, teachers watch and 8-year-olds pretend to revive overdosed patients, or hearing how a parent confesses that they’ve relapsed.

The focus of schools should be learning and teaching kids, but often many kids’ minds are not focused on that, they’re worried about their parents, about their next meal and who’s going to be home to take care of them. When a parent becomes addicted or goes into rehab, it changes everything for a family.

Drug users’ children flooding to foster care

In Tiffany Smith’s case, three years of methadone treatment have helped her regain solid enough footing to secure housing and begin working toward a GED, in hopes of becoming a drug and alcohol counselor. But her children are still reeling. Smith’s 6-year-old cannot stand to be apart from his mother and struggles with speech, cognitive and learning delays.

“He was talking fine before foster care,” Smith said. “But when he came out, he couldn’t pronounce some words. They said it was due to the trauma.”

Her older son, now 7, was born prematurely and spent his first two days of life trembling from heroin withdrawal as his mother watched, devastated. “Seeing my baby shake from detoxing really hurt — I knew it was my fault,” she said.

In Washington state, this number is alarming, but not widely known, 10,000 high-school seniors said they’d used heroin or gotten high on opioid-derived painkillers in 2016, those numbers were about the same as two years prior, but foster care placements have surged.

Between 2011 and 2017, the state took children from drug-abusing parents nearly 14,000 times. Last year’s rate was the highest for drug-related causes since 2010 — up 16 percent over 2015 — while state hospitals report a steady increase in substance-exposed newborns.

Child-welfare workers hear complaints about increasingly severe problems in school — more physical violence toward peers, or kids who need to be taught separately — from students whose parents are staggering through addiction, said Jenna Kiser, who oversees intake at the state Children’s Administration.

Jenny Heddin, a state agency supervisor stated, “These numbers are very concerning, when children from these homes come into foster care, they can be very difficult to serve.”

This represent one corner of a national wave. More than 37 states report unprecedented numbers of kids entering foster care, many of them for reasons related to a parent’s substance abuse, according to the federal Department of Education.

Damaging children’s futures

By the time Child Protective Services is knocking on someone’s door, the problem is already severe. And so far, efforts to respond might best be described as triage — focused more on addiction treatment than prevention, both in Washington and across the country.

As in many other states political infighting prevents treatment, earlier this year, Washington Gov. Jay Inslee proposed spending $20 million on a multipronged effort to combat opioid addiction. The bill never made it to the floor for a full vote, and it contained little funding for prevention. (But $1.7 million targeted for youth did get funding.)

Yet researchers warn that ignoring that aspect of the crisis virtually guarantees costly problems to come as the children of addicts grow into adulthood. Kevin Haggerty, a professor at the University of Washington who studies risk factors for drug abuse, authored one of the few peer-reviewed studies tracking life outcomes for these young people.

In the early 1990s, he identified 151 elementary and middle-school children in Washington who were growing up with heroin-addicted parents. Fifteen years later, as young adults, 33 percent had dropped out of high school. The vast majority were addicts themselves, and half had criminal records. Only 2 percent had made it through college. (Nationally, 33 percent of all kindergartners in 1992 grew up to earn a college degree.)

“The results are astounding at how poor the outcomes are, having a drug-addicted parent,” said Caleb Banta-Green, principal research scientist at the Alcohol and Drug Abuse Institute at the University of Washington’s School of Public Health.

“We need to be doing a lot more for kids being parented by opiate-addicted parents — and we’re not.”

“Families literally bring their problems to our door now to help them navigate their lives,” Harrington-Bacote said. “Public schools are doing things that fall way outside of regular academic education. But if they don’t, it’s not going to get addressed at all.”

OHIO EXAMPLES OF HOW BIG PHARMA OPIOID Rx MONEY DESTROYS LIVES

Way before social workers showed up in his living room this March, Matt McLaughlin, a 16-year-old with diabetes, had taken to a routine not of his doing, trying to scrounge up enough change for food while his mom, Kelly, went out to use heroin. On a good night, the high school junior would walk his neighborhood in Andover, Ohio to pick up frozen pizza from the dollar store, and on bad nights, he’d play video games to keep his mind off his hunger and unknown blood sugar levels.

When Matt was little, his mom Kelly was a Head Start caseworker who taught parents how to manage their autistic children, who hosted potlucks and played Barbie with Matt’s sister, Brianna. “Growing up, we were the house that everyone wanted to come to,” remembered Brianna, now 20. “I loved every minute of it.”

Kelly had neck surgery and got addicted to OxyContin, and by 2015, she was spending her days napping, disappearing for hours at a time, or going to her neighbor’s house, where she would exchange cash for packets of heroin. She started yelling at the kids, food became scarce, life changed for the worse, “It’s like her personality did a 180,” Brianna said. “I felt like I lost my mom to this pit that I couldn’t pull her out of.”

Ashtabula County Children Services a tip when someone called the police and urged them to check on the family.

She’d been to detox several times over the years, trying to rid herself of what felt like a demon that had taken over her brain. Last year, she managed to stay clean for 63 days, until a friend came over “and laid out a line—and that was all it took.” There are five heroin dealers within a five-mile radius and all more than willing to provide an addict the opiate of choice, which is the norm for rural Ohio anymore.

He kids were once again forced to pack their bags as Kelly would go to detox another time, they were lucky to have relatives nearby: The spiraling opioid epidemic has disrupted so many families that all the foster homes in Ashtabula County are full, this story is repeated across the country every day.

The scourge of addiction to painkillers, heroin, and fentanyl sweeping the country has produced a flood of bewildered children who, having lost their parents to drug use or overdose, are now living with foster families or relatives. In Ashtabula County, in Ohio’s northeast corner, the number of children in court custody quadrupled from 69 in 2014 to 279 last year. “I can’t remember the last time I removed a kid and it didn’t have to do with drugs,” says a child services supervisor. Her clients range from preschoolers who know to call 911 when a parent overdoses to steely teenagers who cook and clean while Mom and Dad spend all day in the bathroom. Often, the kids marvel at how quickly everything changed—how a loving mom could transform, as one teenager put it, into a “zombie.”

The pattern mirrors a national trend: Largely because of the opioid epidemic, there were 30,000 more children in foster care in 2015 than there were in 2012—an 8 percent increase. In 14 states, from New Hampshire to North Dakota, the number of foster kids rose by more than a quarter between 2011 and 2015, according to data amassed by the Annie E. Casey Foundation.In Texas, Florida, Oregon, and elsewhere, kids have been forced to sleep in state buildings because there were no foster homes available, says advocacy group Children’s Rights. Federal child welfare money has been dwindling for years, leaving state and local funding to fill in the gaps. But Ashtabula County is one of the poorest counties in Ohio, and despite a recent boost in funding, the state contributes the lowest share toward children’s services of any state in the country.

More Broken Families, Less Funding

Ohio also has one of the nation’s highest overdose rates. In 2016, at least 4,149 Ohioans died of drug overdose—a 36 percent jump from the year before, according to the Columbus Dispatch. In 2015, 1 in 9 US heroin deaths occurred in Ohio.

It’s hard to overstate just how pervasive the epidemic feels here. Detective Taylor Cleveland, who investigates drug cases in Ashtabula, told me, “I’m dealing with ruined homes two and three times a day.” Cleveland, who coaches youth soccer and recently adopted a 17-year-old player whose mom overdosed, leads a task force that responds to every overdose in the county. Once, he arrived at an overdose scene only to realize that the victim slouched over in the motel room was his cousin, whose young daughter had called 911. “Every OD that happens, I get a text. I’ve gotten two texts while we’ve been talking.” We’d been talking for less than an hour.

Given the scale of the crisis, it’s not hard to understand why, when Donald Trump promised Ohioans on the campaign trail to “spend the money” to confront the opioid crisis and build a wall so drugs would stop flowing in, locals in this historically blue county took notice. In late October, Trump became the first presidential candidate since John F. Kennedy to visit Ashtabula County. He promised to bring back jobs, to open the long-shuttered steel plants, to build the wall. Twelve days later, Ashtabula residents voted for a Republican president for the first time since Ronald Reagan in 1984.

WHITE HOUSE PROMISED ON OPIOIDS BUT DIDN’T DELIVER

But since he took office, Trump’s plans to tackle the epidemic head-on have fizzled. Republicans’ recent effort to repeal and replace Obamacare would slash funding for Medicaid, which is the country’s largest payer for addiction services—and which covers nearly half of Ohio’s prescriptions for the opioid addiction medication buprenorphine. The bill would enable insurers in some states to get out of the Obamacare requirement to cover substance abuse treatment. A memo leaked in May revealed Trump’s plans to effectively eliminate the White House’s drug policy office, cutting its budget by 95 percent. (The administration has since backpedaled on the plans, following bipartisan criticism.) Trump’s 2018 budget proposes substantial cuts to the Administration for Children and Families, the Substance Abuse and Mental Health Services Administration, and the Temporary Assistance for Needy Families program.

“I think some people felt as though nothing else is working,” said one Ashtabula resident when I asked why so many in a Medicaid-dependent area would vote for Trump. Now, she says, “I’m really, really scared. You don’t get it until you live in a small town and you see people die every day.”

Like so many other Midwest Rust Belt counties, Ashtabula, Ohio has seen better days. Locals proudly tell me that the Port of Ashtabula used to be one of the biggest in the world, where barges unloaded iron mined from Minnesota’s Mesabi Range onto trains headed for the steel mills of the Ohio River Valley. Today, once-bustling streets have given way to vacant storefronts and fast-food chains; the surrounding countryside is made up of farm fields, trailer parks, and junkyards. One in three kids now live below the federal poverty line, less than half of adults have a high school education. The financial downturn accelerated in the ’90s, when manufacturing jobs started disappearing.

Then Opiate Big Pharma and their marketing campaigns introduced newer “less addictive” painkillers like OxyContin and others like Vicodin were liberally prescribed in communities wrestling with dwindling economic opportunity and rife with workplace injuries common to mines, lumberyards, and factories. As authorities started to tighten the rules on prescribing drugs like OxyContin, the use of heroin, which is chemically nearly identical to opioid painkillers, crept up. But the tipping point, for Ohio and the country, came over the past couple of years, when illicit fentanyl, an opioid up to 100 times more powerful than morphine, started making its way into the heroin supply. Since then, says Dr. Thomas Gilson, the medical examiner for nearby Cuyahoga County, the deaths have been coming “like a tidal wave.”

About five years ago, Ohio noticed a major uptick in the number of parents using heroin. More recently, elected officials have learned more about the parasitic way that opioids co-opt the brain and the complex pull of addictions attitudes have softened, with most realizing, there is no good guy or bad guy, once addiction takes hold. The long term problems are often multiplied many times over by lack of short term treatment.

Gov. John Kasich, a notorious budget hawk, made national news when he pushed Medicaid expansion through Ohio’s conservative Legislature. “When you die and get to the meeting with St. Peter,” he told one lawmaker, “he’s probably not going to ask you much about what you did about keeping government small. But he is going to ask you what you did for the poor.” He made news yet again last week, when he signed a 2018 budget that will, for the first time in years, increase the state’s funding for children’s services. Yet the $30 million boost in funding over two years, which will pay foster parents and provide counseling for the kids, won’t make up for the $55 million increase in child placement costs over the past three years. Other than county pilot programs, “No policy or state investment has focused specifically on the children flooding into county agency custody as a result of the opioid epidemic,” concluded a report by the Public Children Services Association of Ohio this spring.

Meanwhile, federal funding for children’s services decreased by 16 percent between 2004 and 2014. That’s due in part to an arcane law stipulating that the largest pot of federal money for children’s services applies only to kids from below a certain income threshold. In many states, that threshold is about half the poverty level—in Ohio, it’s roughly $14,000 per year for a family of four. But the opioid epidemic has afflicted families of all stripes. “A few years ago, I was constantly just in homes that were clearly in poverty,” says Mongenel. Now she’s struck by her new clients’ well-kept houses: “You pull up to it and it’s like, ‘Really?’”

The director of one Ohio county stated “that more caseworkers are quitting than ever before, unable to reconcile the overwhelming caseload with the paltry salary, which starts at $28,500..’”

Another addiction case is Amber, a 16-year-old whose mother, Emily, was in and out of rehab for a year, while Emily cycled in and out of rehab. In December, officials got the phone call that Emily had been found dead, slumped over in a motel bed, and a social services worker had to break the news to Amber that they had run out of chances, her mother had died. Today, Amber lives in a what is her new home, a bustling house with nine other foster kids.

Then there is Jake, another 6-year-old with boy-band looks who lived for months in a motel over the 2017 winter with his two younger siblings, taking courses online and playing video games, while his mom went out to use. “He just wanted her to go into rehab and get right,” he told a reporter earlier this year, “If that could be my birthday present or my Christmas present, that’s what it would be.”

Lisa is a 10-year-old, introduced to Ohio social services for the first time in a conference room at her elementary school, the agency rep told her “We’re from children’s services have you ever heard of that before?” Lisa nodded and replied “they’re the people who go to her friend’s house once a month to make sure everything is okay,” in a matter of fact way.

Lisa was asked, “Do you have enough to eat?” and “Do you like where you’re staying?” and Do you know what drug use is?” but it wasn’t mentioned that CPS had just visited Lisa’s house and found her father strung out on heroin in the bedroom they share. Lisa’s bed was a pink sleeping bag on a piece of foam surrounded by pill bottles.

Children in Lisa’s situation are subject to incredible psychological stress. There’s the immediate trauma of living with an unstable parent or being taken from family and sometimes from school and friends. But there’s also the long-term impact. Dozens of studies have found that kids who undergo traumatic events early in life are more likely to suffer mental and physical repercussions later on, be it substance abuse, depression, heart disease, or cancer. Among the 10 so-called Adverse Childhood Experiences, or ACEs, are emotional abuse, physical abuse, separation from parents, and parental substance abuse.

“Every time a child gets into a scary or dangerous situation, it activates their stress response,” explains Dr. Nadine Burke Harris, a pediatrician and founder of the Center for Youth Wellness, which focuses on the developmental effects of childhood trauma. “The repeated activation of their stress response is what leads to the biological condition that we in pediatrics are now calling toxic stress.” Looking at the brains of kids of drug users, Burke Harris says, one would expect to see the signs associated with other types of trauma: an enlarged amygdala, the brain’s fear center; decreased functioning of the nucleus accumbens, the brain’s pleasure and rewards center; and less activity in the prefrontal cortex, which oversees a child’s ability to control impulses and pay attention.

CPS and affiliated social services agencies across the United States are now becoming much more familiar with the latest addiction research on ACEs and impacts on young children. They know that a child with four or more ACEs is twice as likely as other kids to develop cancer and ten times more likely to inject drugs themselves. When they encounter someone like Lisa, they are torn between mitigating one ACE, exposure to parental substance abuse, and catalyzing another: separating a child from her parents. Which is what makes these conversations so heart-wrenching.

For county and state professionals, one of the most difficult things about managing opioid cases is how unpredictable they can be, never knowing how a client’s drug-addicted parent will do after detox. Some thrive and are quickly reunited with their families. Others can’t pull themselves out of the black hole of addiction.

One positive outcome amid the many negatives, is the mother of Matt, the diabetic teenager, Kelly had sailed through detox and been sober for nearly a month, her daughter Brianna had moved back in to help her mom. In the fall Brianna is leaving for college—training to be a social worker, Kelly joked “I’m going to be her first case,” and added “When I was using, I would sleep half the day away” and wake up feeling sick from heroin cravings, she said. “Now I’ve been setting my alarm. I wake up early, enjoy my coffee, open the blinds, and let in the sunshine.” On her walks to town, she said, she crossed the street and looked straight ahead to avoid catching a glimpse of her dealer’s house, an ever-present temptation. Brianna and Matt often visit Kelly at an addiction treatment center.

Every 19 minutes, an opioid addicted baby is born in America., while many of us are well aware of the repercussions of addiction in adults, but very little is understood about the impact it has on infants. After months of being fed opioids through the mother, these babies suffer through excruciating pain.

Imagine, then, how it feels for a baby. Infants who have been exposed to opioid painkillers like morphine, codeine, oxycodone, methadone treatment or street drugs such as heroin while in utero are literally cut off from the drugs when they are born. Within their first 72 hours of life, about half of the babies who have been exposed begin having withdrawal symptoms.

The medical term for this is neonatal abstinence syndrome, or NAS, and rates of babies born with it are rising along with the exponential increase of painkiller use and abuse.

A recent analysis by the Centers for Disease Control estimated that nearly six out of every 1,000 infants born in the U.S. are now diagnosed with NAS. However, experts say that rate is likely higher, as not all states regularly collect such data.

In the USA, Opioid use by women in rural areas is driving the increasing numbers. Tennessee is part of a cluster of states, including Alabama and Kentucky, experiencing some of the highest rates of NAS births. In East Tennessee the problem is particularly acute: Sullivan County alone reported a rate of 50.5 cases of NAS per 1,000 births, the highest rate in the state for five years running.

Tennessee is currently the only state in the country that equates substance abuse while pregnant with aggravated assault, punishable by a 15-year prison sentence. Eighteen other states consider it to be child abuse, and three say its grounds for civil commitment. Four states require drug testing of mothers and 18 require that healthcare professionals report when drug abuse is suspected. There are also 19 states that have created funding for targeted drug treatment programs for pregnant women.

Opponents of the punishment philosophy claim that punishing addicted pregnant women will not stop them from abusing drugs â€“ instead it will stop them from seeking prenatal care. Many also claim that these policies would unfairly punish mothers for drug use compared to fathers. Organizations, such as the American Civil Liberties Union (ACLU) and the American Congress of Obstetricians and Gynecologists (ACOG), have encouraged a treatment over punishment approach for pregnant mothers with drug addictions.

Opioid use by women in rural areas is driving the increasing numbers. Tennessee is part of a cluster of states, including Alabama and Kentucky, experiencing some of the highest rates of NAS births. In East Tennessee the problem is particularly acute: Sullivan County alone reported a rate of 50.5 cases of NAS per 1,000 births, the highest rate in the state for five years running.

In Canada, in the past decade, the number of babies exposed to opioids in the womb has increased 16-fold in Ontario. And according to Ontario’s Provincial Council for Maternal and Child Health (PCMCH), more than 950 infants were born to opioid-addicted mothers last year. Just over half of them will live the toughest days of their lives in their first week outside the womb.

Until the governments at the federal, state and local levels can all agree on a long term viable solution to the opioid crisis and the impact on school age children, infants born addicted and society as a whole, the opiate drug crisis will linger for generations long into the future.